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

Catalog Number	AMC2010
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the video provided by the hospital, we have confirmed the reported incident.However, the amount of oozing seems to meet our specifications although this could not be confirmed.We could not determine the exact root cause of the defect since the device remains implanted in the patient.However, we performed qc testing on two grafts from the same lot that we had in us inventory.When we performed qc blood leakage testing on these grafts, they met our specification.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.Further, we have not confirmed any other complaints of similar nature for devices from this lot.Our lot distribution records show that 45% (n=78) units from this lot have been implanted without issue.Further, we have sold 100% of the lot mostly in 2015 and 2016.Although we are inconclusive about the root cause of the defect, it is possible that the graft was stored or handled improperly.There was no injury to the patient as the result of this incident.The oozing stopped after 10 minutes.The graft remains implanted in the patient.
Event or Problem Description
During treatment of patient with abnormal aortic aneurysm, albograft was implanted.After unclamping at the aorta, the graft started oozing blood.Patient had been treated with standard load of heparin.After 10 minutes of implantation, bleeding stopped.Graft remains implanted in the patient with no clinical sequelae.

• 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: 6785741
• Report Number: 1220948-2017-00046
• Device Sequence Number: 13825449
• 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): 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 04/28/2019
• Device Catalogue Number: AMC2010
• Device Lot Number: 128335
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2017
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR