MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. LIFESPAN EPTFE VASCULAR GRAFT; VASCULAR GRAFT PROSTHESIS

Model Number	R06080C80
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When the surgeon attempted to remove the spiral of the lifespan vascular graft, a section of the tape lamination peeled off.So, the surgeon did not implant the graft.
Additional Manufacturer Narrative
We have not received the complaint device for evaluation since it was discarded by the user.However, we have confirmed the reported incident in the picture that was provided to us.In the picture, we observed a section of the tape peeled.Without the returned device, we remain inconclusive on the exact cause of the malfunction.Our review of the lot history records for this lot did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.We did not find any discrepancy in the tape wrapping and lamination step that could be related to this defect.All of the parameters documented in the batch records were found to be within specification.Please note that we conduct 100% inspection of the grafts.Each of the grafts is inspected for holes, tape-related defects, kinks, stains, dents, and wrinkles during our in-process inspection.The qc inspector also inspects a sample of these grafts for those defects.We have also reviewed our complaint history for the last 5 years.We have not received any other complaints of a similar nature.Hence, we consider this to be an isolated incident.The user detected the malfunction during the pre-use check.So, he implanted another graft.

• Brand Name: LIFESPAN EPTFE VASCULAR GRAFT
• Common Device Name: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 14465954
• Report Number: 1220948-2022-00040
• Device Sequence Number: 4904291
• Product Code: DSY
• UDI-Device Identifier: 00840663105601
• UDI-Public: 00840663105601
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K130016
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: R06080C80
• Device Catalogue Number: R06080C80
• Device Lot Number: LVG3282A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 05/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown