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

Catalog Number	AP10100R
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
We have not received the device for evaluation since the device remains implanted in the patient.A visual inspection performed on this exact patch on december 22, 2017 passed all the qc requirement.The inspection ensured that the patch was smooth, collagen was evenly impregnated throughout the graft, and there were no holes, broken threads or any loose fibers in the patch.Another released patch from our inventory from the same lot number ( serial (b)(4) lot# 204574) was also visually inspected.We did not find any defect with this patch.The collagen was evenly distributed throughout the patch.No pinhole was detected in this patch.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.(b)(4) albosure patches were manufactured under this lot number.(b)(4) units 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.The hole in the patch led to a prolonged haemostasis.The hole was sewed using a 6-0 suture.
Event or Problem Description
A hole was detected in an albosure patch during carotid angioplasty.The hole was sewed using a 6-0 suture.This is report 1 of 2.We have also submitted another complaint related to a similar incident that occurred with albosure patch ( lot# 186578 serial (b)(4)) mfr report # 1220948-2018-00056 reported to us by the same surgeon from the same hospital.

• Brand Name: ALBOSURE POLYESTER VASCULAR PATCH
• Common Device Name: CARDIOVASCULAR PATCH
• Manufacturer (Section D): LEMAITRE VASCULAR, INC.; 63 second ave; burlington MA 01803
• MDR Report Key: 7773598
• Report Number: 1220948-2018-00055
• Device Sequence Number: 1950647
• Product Code: DXZ
• UDI-Device Identifier: 00840663104802
• UDI-Public: 00840663104802
• Combination Product (Y/N): N
• PMA/510(K) Number: K101740
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/10/2018

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: Health Professional
• Device Expiration Date: 11/28/2023
• Device Catalogue Number: AP10100R
• Device Lot Number: 204574
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2018
• Initial Report FDA Received Date: 08/10/2018
• 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: Required Intervention