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

Catalog Number	AMC2010
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	11/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have received the graft for evaluation.When the graft was observed visually, we did not find any holes or external defects in the graft that could have contributed to this issue.The physical incubation test (which measures how well the collagen was impregnated into the graft) previously performed on a portion of this exact complaint device was found to be acceptable.An unused graft from the same lot number was tested for water permeability during this investigation.The graft passed this test.Our review of the lot history records for this lot did not find any discrepancies at the finished good, sub assembly or raw material phase of production that could be related to this incident.Our lot distribution records show that (b)(4) units from this lot have been sold.We have not received any other complaints from customers related to a similar issue.We are inconclusive about the root cause of the defect and consider it an isolated incident.There was no injury to the patient as the result of this incident.
Event or Problem Description
Albograft vascular graft amc2010 lot# 140129 serial number (b)(4) was used during open aorta aneurism treatment.After performing proximal anastomosis, the graft start to bleed when the clamp was removed.So, another lemaitre albograft was used to complete the procedure.

• 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: 7123279
• Report Number: 1220948-2017-00072
• Device Sequence Number: 2036801
• Product Code: MAL
• UDI-Device Identifier: 00840663103492
• UDI-Public: 00840663103492
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/15/2017

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: Physician
• Device Expiration Date: 10/28/2021
• Device Catalogue Number: AMC2010
• Device Lot Number: 140129
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 12/15/2017
• 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