MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. XENOSURE BIOLOGICAL PATCH; MESH, SURGICAL

Catalog Number	E1P6
Medical Device Problem Code	Delamination (2904)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have received the device for evaluation.However, we could evaluate the complaint device since it was returned to us dry.As a result, the patch has shrinked significantly and had lost all of its physical and chemical properties.We received 5 small pieces of the patch.We could not conclusively determine the root cause of the defect.Device was checked by the operating team prior to the start of the procedure and was found to be acceptable.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.All of the (b)(4) units of the xenosure patches manufactured in this lot number has been sold.We have not received any other complaints of similar nature for devices from this lot.There was no injury to the patient as the result of this incident.Procedure was completed by implanting a new patch.We have contacted the hospital to provide us with further information on this case.However, we have not yet heard anything back from the hospital.
Event or Problem Description
Xenosure patch frayed after being sutured in the patient.So, the patch was explanted and replaced with an another patch.

• Brand Name: XENOSURE BIOLOGICAL PATCH
• Common Device Name: MESH, SURGICAL
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7100932
• Report Number: 1220948-2017-00070
• Device Sequence Number: 1874232
• Product Code: FTM
• UDI-Device Identifier: 00840663106288
• UDI-Public: 00840663106288
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040835
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/08/2017

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: 07/05/2017
• Device Catalogue Number: E1P6
• Device Lot Number: XBU2833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/08/2017
• 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