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

Model Number AG640

Device Problems Material Puncture/Hole (1504); Material Integrity Problem (2978)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 06/12/2023

Event Type  malfunction  

Event Description

Patient (b)(6) (54yr old male) had left fem pop on (b)(6) 2023 where 2 artegrafts were stitched together for total length needed.Ag740 anastamosis proximal & approx 5-6cm of ag640 stitched to it distal.Patient presented in er with hemotoma and bleeding from site on (b)(6) 2023.Hemotoma from above knee to below knee area.Er applied tourniquet to stop bleeding which clotted the graft.Patient taken to surgery and dr noticed hole in graft in section that was 5mm (ag640) section.-distal to connection of grafts.Graft was de-clotted and repaired with bovine patch/ xenosure.Patient was reported as still in icu and now in renal failure.An updated report was received from the sales representative on (b)(6), 2023: was advised by vasc coord (b)(6) at this hospital today that the patient was taken back to surgery on (b)(6), for an aka (above knee amputation).Patient was bleeding from incision and couldn't stop after giving fresh frozen.The patient is high risk cardiac, no autologous saphenous veins to use and didn't want to use synthetic graft due to possible infection (elevated white count).Patient had bad rest pain in this foot so he made clinical decision to amputate above knee patient expired in hospital icu.He was in respiratory distress with copd and refused to be put on ventilator.Patient also had cirrhosis of the liver.He was dnr.Graft was only accessed once on original revision on (b)(6), 2023 when hole was repaired with xenosure.

Manufacturer Narrative

Artegraft instructions for use (ifu) indications for use section states that the use of artegraft for femoropopliteal bypass should be reserved for those patients where the autologous saphenous vein is absent or inadequate.It is also not recommended for reconstruction across the knee joint.However, in the absence of other viable alternatives, the surgeon may well find the benefit to risk ratio warrants its use as an attempted limb salvage procedure.The graft involved was not received for evaluation so the issue was not able to be confirmed.The issue was identified after graft had been implanted for 66 days.The affected portion of the graft was repaired with bovine patch/xenosure.Graft was only accessed once on original revision on (b)(6) 2023 when hole was repaired with xenosure.A review of complaint data within the past three years was completed and there were no indications or trends identified that would suggest an increase in holes in grafts that have been fully processed.As 100% of the grafts are pressure tested and visually inspected prior to release, we remain inconclusive about the root cause of the issue.Based on the documentation and complaint history review, we do not believe there is a systemic issue with these devices.No further actions were determined to be necessary at this time; all product quality and clinical issues will continue to be monitored within quality assurance trending.

Manufacturer Narrative

Clinical review of the events indicated that the issue was most likely caused as a result of some form of physical stress that popped off one of the ties on the branches or in fact part of the sutured anastomosis tore.Based on the documentation and complaint history review, there is no evidence to suggest a systemic issue with these devices.

• 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 08902
• Manufacturer Contact: monte nelson ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 17326565
• MDR Text Key: 319314381
• Report Number: 2247686-2023-00005
• Device Sequence Number: 1
• Product Code: LXA
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AG640
• Device Catalogue Number: N/A
• Device Lot Number: 21LL328-002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2023
• 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 Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 129 KG
• Patient Race: White