MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number AG636

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2021

Event Type  malfunction  

Manufacturer Narrative

An artegraft collagen vascular graft was returned for evaluation.The lot number of the product culture tube returned for evaluation differed from the initial lot number reported (reported lot 20k327-036 and returned lot 20j315-008).Clarification for the correct lot number related to the complaint allegation and the lot number of the product returned was requested from the complainant; to date no response was received.Additional clarification was also requested for the customer statement "the balloon did not inflate" as the artegraft collagen vascular graft product does not contain a balloon.The returned product was visually inspected and pressure tested per release criteria.The evaluation indicated that the graft length did not match the release length of either possible lot number provided.The edge of the graft was not a straight cut and was likely trimmed by the customer after opening.The returned product graft was stuck to lid inside the tube (it is unclear how this occurred).Pressure testing of the returned product verified excessive bubble formation at the graft side walls; no tributaries were identified as showing bubbles.Our review of the lot history records for both batch numbers (20k327 and 20j315) did not find any discrepancies either in the manufacturing or packaging process that could be related to this incident.During the manufacturing process, the exact graft was inspected by a manufacturing technician for holes in the graft and proper ligation of the tributaries.No defect was noted during the inspection process.All grafts from these product batch numbers were also tested for pressure test.All of the samples met specifications.Further, we have not received any other complaints of a similar nature from either possible product batch, 20k327 and 20j315.Therefore, we believe that it was an isolated incident.We have also reviewed our complaint history records for last 2 years and searched for a similar issue where a hole/tear was found in an artegraft collagen vascular graft; there is no confirmed trend was identified for this issue.We remain inconclusive about the root cause of the issue, but based on the documentation and complaint history review, we do not believe there is a systemic issue with these devices.No corrective action is needed at this time.The issue was identified during pre-implant preparation and the graft was not utilized; there was no reported patient adverse event.The complaint issue will continue to be monitored within quality assurance trending and if action is required, appropriate investigation will be performed.

Event Description

A lemaitre sales representative received an email notification from the hospital stating "recently the staff was opening an ag636 artegraft for a case and they said it was leaking and the balloon did not inflate.From my understanding it was not implanted in the patient." no patient adverse events were reported.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 11697296
• MDR Text Key: 250269180
• Report Number: 2247686-2021-00001
• Device Sequence Number: 1
• Product Code: LXA
• UDI-Device Identifier: 00316837000237
• UDI-Public: (01)00316837000237(17)231031(10)20J315-008
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: AG636
• Device Catalogue Number: Ag 636
• Device Lot Number: 20J315-008
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 33 YR