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

Catalog Number	1009-00
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/18/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The graft has been implanted in the patient.However, a piece of the remaining graft that was not implanted was returned to us for evaluation.When we inspected the device through naked eyes as well as through the microscope, we did not observe any excessive collagen on the graft.All of the collagen appeared to have been impregnated correctly inside the crimps of the graft.We performed testing on this device to determine the amount of the collagen that was coming off the graft as well as the total content of the collagen in the graft.We found the release of the collagen met specification and the total collagen content in the graft was also within our specification.At this time, we are inconclusive about the root cause of the issue.The device was sold to the hospital on 05/18/2017.We have conducted a lot history review and did not find any issues noted in the manufacturing or packaging process that could be related to this issue.All qc tests passed their requirements.Out of (b)(4) units released for sale, we have sold (b)(4) units to different hospitals.We have not received any other complaints of similar nature for devices from this lot.We therefore believe this is an isolated incident.
Event or Problem Description
During thoracic aorta replacement, after first anastomosis, the collagen seems to come off from the graft.However, the haemostasis was found to be satisfactory after a few minutes.The graft remains implanted in the patient.

• 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: 6661525
• Report Number: 1220948-2017-00041
• Device Sequence Number: 45979
• Product Code: MAL
• UDI-Device Identifier: 00840663106677
• UDI-Public: 00840663106677
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/22/2017

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: 05/28/2018
• Device Catalogue Number: 1009-00
• Device Lot Number: 99104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/23/2017
• Initial Report FDA Received Date: 06/22/2017
• 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: Other