MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOGRAFT KNITTED COLLAGEN BIFURCATED GRAFT 14X7; ALBOGRAFT BIFURCATED GRAFT

Model Number	AMC1407
Medical Device Problem Code	Device Issue (2379)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received a portion of the complaint device for evaluation and were able to verify the failure.The "jelly" material was collagen from the graft.This specific graft had excessive collage on the outer and inner surfaces of the graft.The complaint lot history records review did not reveal any discrepancies related to the complaint event during the manufacturing process.The complaint lot passed all required tests.We have also not received any other complaints for devices from this lot.Therefore, it was an isolated incident.However, we made our manufacturing associates aware of this complaint and reviewed the complaint device with the manufacturing supervisor and qc inspectors.Please note that the device remains implanted and did not affect the procedure or it's outcome.In most cases, the excessive collagen is considered as a cosmetic defect.
Event or Problem Description
During implantation the physician noticed a "jelly" material stuck to the walls of the graft's leg.It came off when the physician tapered the graft's leg with scissors.The graft was implanted and remains implanted.A small portion of the graft was cut and returned for evaluation.The physician noted that this observation did not affect the outcome of the procedure.

• Brand Name: ALBOGRAFT KNITTED COLLAGEN BIFURCATED GRAFT 14X7
• Common Device Name: ALBOGRAFT BIFURCATED GRAFT
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second avenue; burlington MA 01803
• MDR Report Key: 5635183
• Report Number: 1220948-2016-00009
• Device Sequence Number: 13459363
• Product Code: MAL
• UDI-Device Identifier: 00840663103430
• UDI-Public: 00840663103430
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K103080
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/07/2016

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: 04/30/2019
• Device Model Number: AMC1407
• Device Catalogue Number: AMC1407
• Device Lot Number: 128335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2016
• Initial Report FDA Received Date: 05/05/2016
• 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