MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOGRAFT POLYESTER VASCULAR GRAFT; VASCULAR PROSTHESIS

Model Number	AMC3006
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We could not perform a hands-on evaluation on the graft since it has been discarded by the user facility.We have sent a list of follow-up questions to the hospital but we have not yet received a response despite our repeated attempts.The investigation is ongoing, but our inquiries are not getting any more response due to the increasing covid-19 situation in (b)(6).We have released a total of (b)(4) units of albograft vascular graft from this lot number.This graft catalog# amc3006; lot# 243996, serial# (b)(4) was sold to the hospital on november 11, 2019.We have not received any other complaints related to a similar incident for this lot number.Our review of the batch history for this device did not reveal any issues that could have caused this incident.We have also reviewed our complaint history for last 5 years.We did not find any other complaints related to a similar issue reported to us by other hospitals.Please also refer to manufacturer incident report# 1220948-2020-00107 relating to another case of thrombosis that occurred at the same hospital after implanting albograft vascular graft.We have received a total of two complaints from this hospital on the same day for this issue with the same exact description which raises questions on how these grafts were prepared and implanted, including any postoperative care provided to the patients.We have also reviewed our risk document.The current rate of occurrence for this issue is within our expected rate.Our ifu mentions a list of potential complications including thrombosis that occur with the use of albograft vascular graft.
Event or Problem Description
Prosthesis thrombosis.Fem-pop arterial bypass.Need of another surgery to replace it.

• Brand Name: ALBOGRAFT POLYESTER VASCULAR GRAFT
• Common Device Name: VASCULAR PROSTHESIS
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 10795852
• Report Number: 1220948-2020-00106
• Device Sequence Number: 16856246
• Product Code: MAL
• UDI-Device Identifier: 00840663102822
• UDI-Public: 00840663102822
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K093231
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: AMC3006
• Device Catalogue Number: AMC3006
• Device Lot Number: 243996
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention