The FDA has informed health care providers that the Weck Hem-o-Lok Ligating Clip could cause serious risk for the donor when used for renal artery ligation during a laparoscopic living-donor nephrectomy and should not be used.
The FDA states, “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.”
During surgery, the FDA has found that clips can become dislodged during surgery. This causes the following issues:
- uncontrolled bleeding
- additional surgery
- death of the donor.
The manufacturer of these clips added this information to the Instructions for use in 2006. Between 2001 and 2005 15 reports of 12 injuries and three deaths were submitted necessitating this label change. Since this label change, there have been three more kidney donor deaths all of which were associated with the aforementioned issues.
Both the Organ Procurement and Transplantation Network (OPTN) and the American Society of Transplant Surgeons issued have sent separate notifications to their members and to all OPTN-sanctioned kidney transplant systems involving living donors.
The FDA States:
“To help us learn as much as possible about the adverse events associated with Hem-o-Lok Ligating Clips, please include the following information in your reports:
• Manufacturer’s Name
• Device Name (Brand Name)
• Date Device was Manufactured
• Distributor’s Name
• Details of Adverse Event and Medical and/or Surgical Interventions
• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm“