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	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/28/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was discarded by the user facility.Therefore, we cannot conclusively determine the root cause of the defect.During abdominal aortic aneurysm, surgeon saw blood leakage from albograft after he unclamped.So, he changed to a new albograft with a different lot number.There was no injury to the patient as the result of this incident.Patient has been discharged from the hospital.Our review of this lot history records for this lot did not find any discrepancies in either the manufacturing or packaging process that could be related to this incident.There were no non-conforming material reports associated with this crosslinking batch.(b)(4) were manufactured under this lot number and we have not received any other complaints of similar nature for devices from this lot.
Event or Problem Description
The surgeon found blood leakage at the body of the albograft when he unclamped.

• 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: 6324269
• Report Number: 1220948-2017-00007
• Device Sequence Number: 1016521
• 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: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2017

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: 10/28/2017
• 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: 01/13/2017
• Initial Report FDA Received Date: 02/10/2017
• 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