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

Catalog Number	AMC1407
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	01/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During aorta-iliac bypass with prothetic graft, after unclamping, surgeon found the blood leaking from the body of the albograft.So, he clamped the device again and unclamped it once the bleeding had stopped.The device remains implanted in the patient.Patient has been discharged from the hospital.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.No non-conforming material report are associated with the crosslinking batch, impregnation lot or the subassemblies associated with this graft.Further, we have not received any other complaints of similar nature for devices from this lot.
Event or Problem Description
The surgeon commented that when he unclamped, he found the blood leaking from the body of the albograft.

• 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: 6369965
• Report Number: 1220948-2017-00020
• Device Sequence Number: 16312164
• Product Code: MAL
• UDI-Device Identifier: 00840663103430
• UDI-Public: 00840663103430
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2017

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: AMC1407
• Device Lot Number: 88032
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2017
• Initial Report FDA Received Date: 03/01/2017
• 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