MAUDE Adverse Event Report: LEMAITRE VASCULAR, INC. ALBOSURE POLYESTER VASCULAR PATCH; CARDIOVASCULAR PATCH

Catalog Number AP08075T

Device Problem Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 07/04/2018

Event Type  Injury  

Manufacturer Narrative

We have not received the device for evaluation since the device remained implanted in the patient.A visual inspection performed on this exact patch on may 18, 2017 passed all the qc requirement.The inspection ensured that the patch of the graft was smooth, collagen was evenly impregnated though out the graft and there was not holes, broken thread or any loose fibres in the graft.As part of our investigation, we conducted a lot history records review for this product, which did not reveal any discrepancies during the manufacturing processes that could be related to the complaint event.All of the quality control tests passed with expected values.Specifically, the physical incubation test (which measures how well the collagen was cross-linked), water permeability, and puncture test performed on a portion of the same exact graft demonstrated that the grafts from this lot performed as expected at the time of release.Out of (b)(4) albosure patches manufactured in this lot number, (b)(4) units from this lot number have been sold.We have not received any other complaints of a similar incident related to this lot number.At this time, we are inconclusive about the root cause of the incident.

Event Description

Two holes were detected in an albosure patch during carotid angioplasty.This is report 2 of 2.We have also submitted another complaint related to a similar incident that occurred with albosure patch ( lot# 204574 serial (b)(4)) mfg report# 1220948-2018-00055 reported to us by the same surgeon from the same hospital.

• Brand Name: ALBOSURE POLYESTER VASCULAR PATCH
• Type of Device: CARDIOVASCULAR PATCH
• 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: 7773601
• MDR Text Key: 116788034
• Report Number: 1220948-2018-00056
• Device Sequence Number: 1
• Product Code: DXZ
• UDI-Device Identifier: 00840663104604
• UDI-Public: 00840663104604
• Combination Product (y/n): N
• PMA/PMN Number: K101740
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Catalogue Number: AP08075T
• Device Lot Number: 186578
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention