MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOGRAFT KNITTED COLLAGEN BIFURCATED GRAFT 16X8

Model Number	AMC1608
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/16/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the complaint device for evaluation and were not able to verify the failure.The complaint device remains implanted.A lot history records review for this batch did not reveal any discrepancies related to the complaint event during the manufacturing processes.All of the quality control tests passed with expected values.Therefore, the root cause of the failure remains inconclusive.However, we believe it was an isolated incident.(b)(4) and no other complaints have been received.Please note that the complaint graft remains implanted and no permanent injury to the patient happened due to this incident.
Event or Problem Description
The graft was leaking during the implantation.The physician had to use the blood circulating machine for blood transfusion (about 800 cc).The bleeding was stopped with cellulose wadding.The graft remains implanted.Patient is okay.

• Brand Name: ALBOGRAFT KNITTED COLLAGEN BIFURCATED GRAFT 16X8
• Common Device Name: ALBOGRAFT KNITTED COLLAGEN BIFURCATED GRAFT 16X8
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• MDR Report Key: 5732537
• Report Number: 1220948-2016-00012
• Device Sequence Number: 880509
• Product Code: MAL
• UDI-Device Identifier: 00840663103454
• UDI-Public: 00840663103454
• Combination Product (Y/N): N
• Initial Reporter Country: VM
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/23/2016

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: 07/31/2017
• Device Model Number: AMC1608
• Device Catalogue Number: AMC1608
• Device Lot Number: 84477A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2016
• Initial Report FDA Received Date: 06/17/2016
• 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: Other; Required Intervention