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

Catalog Number E0.8P8

Device Problem Material Rupture (1546)

Patient Problem Tissue Damage (2104)

Event Date 07/01/2016

Event Type  malfunction  

Manufacturer Narrative

Through communication with the physician we were able to learn that the fogarty catheter was about 1/3 inflated upon removal through the patch.Additionally, the user was removing clot material from the vessel, thereby increasing surface area of material that was passing through the graftotomy along with the expanded balloon.It is likely that this excess material led to strain on the graftotomy area and created a tear.Our device tracing system was able to determine that the user had also implanted several other patches from this same lot without any reported issues.Our lot history review did not discover any issues related to the manufacturing or packaging of this lot.Our investigation, including consultation with our medical director, concluded that this issue was likely due to operator influence and that the device was not likely the cause of the issue.The report was initially submitted on 02aug2016 through mail.However, on 8/16/2016 we received letter from fda to submit the form electronically.

Event Description

The customer reported that during a femoral endarterectomy procedure with patching, the device experienced a transverse tear.The physician intervened by performing a graftotomy ( cutting of the patch ) and passing of a 4f fogarty catheter to clear the obstructions both proximally and distally to the graft site.After passing the fogarty repeatedly thought the graftotomy site, the patch experienced a transverse tear to the suture line.Doctor removed patch and discarded, replaced with another patch.

• 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: 5886684
• MDR Text Key: 53446151
• Report Number: 1220948-2016-00014
• Device Sequence Number: 1
• Product Code: FTM
• 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: Other
• Type of Report: Initial
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 01/28/2019
• Device Catalogue Number: E0.8P8
• Device Lot Number: XBU1605
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other