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

Catalog Number UNKNOWN

Device Problem Occlusion Within Device (1423)

Patient Problems Wound Dehiscence (1154); Stroke/CVA (1770); Death (1802); Pseudoaneurysm (2605)

Event Type  Death  

Manufacturer Narrative

Patient is known to be diabetic/hypertensive and had recently quit smoking.We have not received the patch for evaluation from the hospital.Hence, we could conclusively determine the relationship of the patch to the reported adverse event.This report was uncovered during the sales rep.Interaction with the physician at roughly 6 months after this issue occured.Therefore, the information provided was from the doctor's recollection not immediately following this event.Lemaitre was made aware of this event (by the doctor) on 8/29/2017.Since the specific lot number was not known, a comprehensive review of all the lot history records sold to the customer was conducted.There were no discrepancies noted that would result to this issue.We also have not received any other complaints from other customers for these lots related to similar issue.We did present this case to our medical director who has extensive experience with bovine patches.Upon review of the case information, he believes that the xensure patch was not a contributor to the issue and was the result of the infection caused by external sources or carriers most likely at the time of surgery and did not originate with the patch material.The investigation is ongoing.

Event Description

Patient experienced dehiscence, pseudoaneurysm and stroke after 2 weeks of implantation of xenosure patch.Patient was deceased at 1 month post operation.

• Brand Name: XENOSURE BIOLOGICAL PATCH
• Type of Device: MESH, SURGICAL
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer (Section G): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• Manufacturer Contact: pragya thikey ; 63 second ave; burlington, MA 01803 ; 7812212266
• MDR Report Key: 6902574
• MDR Text Key: 87721355
• Report Number: 1220948-2017-00057
• Device Sequence Number: 0
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040835
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death