FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraind

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http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm253237.htm

FDA and HRSA Joint Safety Communication: Weck Hem-o-Lok Ligating Clips Contraindicated for Ligation of Renal Artery During Laparoscopic Living-Donor Nephrectomy

Date Issued:  May 5, 2011

Audience: Urologists, Transplant Surgeons, Kidney Transplant Physicians, Hospital Administrators, Hospital Risk Managers, Clinical Transplant Coordinators, Operating Room Supervisors and Staff, and Patients

Medical Specialty: Kidney Donor Transplant Surgery, (Tertiary) Surgery Care, Hospital and Other Medical Center Kidney Programs

Purpose: The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are alerting health care providers that Weck Hem-o-Lok Ligating Clips should NOT be used for the ligation of the renal artery during a laparoscopic living-donor nephrectomy because of serious risks to the donor.

Weck Hem-o-Lok Ligating Clips:
The Weck Hem-o-Lok Ligating Clip is a V-shaped clip made from a non-absorbable material that comes in various sizes.  It is used to permanently close bleeding vessels or tissue structures.

Contraindication for Use:
Weck Hem-o-Lok Ligating Clips that are indicated for laparoscopic use are contraindicated for ligation of the renal artery during laparoscopic living-donor nephrectomies.  This includes the following clips and model numbers: Weck Hem-o-Lok ML Medium Large Endo 5 (544230), Weck Hem-o-Lok L Large (544240), Weck Hem-o-Lok XL Extra Large (544250) and Weck Endo5 Hem-o-Lok Medium Large (ML) Automatic Endoscopic Applier (543965).  The clips may become dislodged, which can lead to uncontrolled bleeding, additional surgery, and/or death of the kidney donor.  Complications have occurred within hours of surgery.

Background:
In April 2006, the manufacturer of Weck Hem-o-Lock Ligating Clips, Teleflex Medical, added this contraindication to the Instructions for Use after receiving 15 medical device reports of 12 injuries and three deaths, all of which occurred between Nov. 19, 2001 and March 20, 2005. All reports were associated with using the clips for ligation of the renal artery during laparoscopic living-donor nephrectomies.
Since the contraindication issued in 2006, there have been three more kidney donor deaths, all associated with the contraindicated use.
While there are published journal articles that appear to endorse the continued use of Weck Hem-o-Lok Ligating Clips for ligating the renal artery during laparoscopic living-donor nephrectomies, the FDA and HRSA are stressing to health care providers that the clips are contraindicated for this use because of potential life- threatening complications.
In January 2011, the Organ Procurement and Transplantation Network (OPTN), operated under contract with HRSA, and the American Society of Transplant Surgeons (ASTS) issued separate safety notifications reinforcing the contraindication to their members and to all OPTN-approved living-donor kidney transplant programs.

Recommendations:
Urologists and Kidney Transplant Surgeons:
Do NOT use Weck Hem-o-Lok Ligating Clips for the ligation of the renal artery during laparoscopic living-donor nephrectomies.

Hospital Staff:
Remind urologists, transplant surgeons, and operating room staff that Weck Hem-o-Lok Ligating Clips should NOT be used for the ligation of the renal artery during laparoscopic living-donor nephrectomies because of the risk to living-donors.

Patients:
If you are considering donating a kidney, talk to your health care provider about:
potential for surgical complications;
methods used during living-donor surgery, and the advantages and disadvantages of each method; and
risks and benefits associated with donating a kidney.
If you have donated a kidney and have any questions or concerns about your surgical procedure, contact your doctor.

FDA and HRSA Activities:
The FDA and HRSA are working together to alert health care providers that Weck Hem-O-Lok Ligating Clips are contraindicated for use in ligating the renal artery during a laparoscopic living-donor nephrectomy.

Reporting Problems to the FDA:
Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with Hem-o-Lok Ligating Clips, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities.

To help the FDA learn as much as possible about the adverse events associated with Hem-o-Lok Ligating Clips, please include the following information in your reports, if available:
Manufacturer's Name
Device Name (Brand Name)
Date Device was Manufactured
Distributor's Name
Details of Adverse Event and Medical and/or Surgical Interventions (if required)
Contact Information:
If you have questions about this communication, please contact the Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at DSMICA@FDA.HHS.GOV, 800-638-2041, or 301-796-7100.