MAUDE Adverse Event Report: ARTEGRAFT, INC. ARTEGRAFT; COLLAGEN VASCULAR GRAFT

Model Number AG840

Device Problem Material Puncture/Hole (1504)

Patient Problem Hematoma (1884)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Artegraft, inc.Identified the adverse event (report number (b)(4)) on 02/06/2020 during a routine review of the (b)(4) database.The adverse event was submitted directly by the hospital to the fda as a user report and a copy was not received by artegraft, inc.The artegraft, inc.Aware date is (b)(6) 2020.In follow-up communications, the implanting physician reported to the local sales representative that following the graft repair, the patient is "doing great".Additional information and details including patient information was requested but has not yet been received.It was also requested if the graft was pressure tested per the ifu prior to implant.As this is a known possible issue, artegraft, inc.Instructions for use include instructions for pressure testing each graft prior to implant.The preparation for implant section states, "artegraft is manometry pressure tested and quality inspected.Before implanting, occlude one end of graft and pressure test with syringe filled with saline solution." a review of the device history record for batch 19d109 was performed; no abnormalities were identified.All grafts released from batch 19d109 passed the requirements for release, including pressure testing, sterility testing, and final visual inspection prior to release to finished goods.To date, no additional complaints were reported from this product batch.A review of the implant record verifies that graft lot 19d109-047 was implanted by dr.(b)(6) on (b)(6) 2019.As the graft lot 19d109-047 remains implanted, it is unavailable for evaluation at artegraft, inc.Artegraft, inc.Manufacturing personnel were made aware of this event.This issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.

Event Description

Review of the fda (b)(4) database identified a report related to artegraft, inc.; report number (b)(4)."pt had a femoral bypass on (b)(6) 2019 during which a bovine carotid artery graft "artegraft" was utilized.Pt presented in clinic on (b)(6) 2019 with lower abdominal hematoma.Pt taken emergently to operating room for exploration of graft site and possible repair.It was discovered that there was no bleeding from the anastomosis site.However, at 6 cm proximal to the distal anastomosis there was pulsatile bleeding from a tear drop shaped hole that was controlled with the placement of a suture.The surgeon identified the hole was possibly related to where one of the side branches would have been tied off by the manufacturer on the bovine artery.Risks that had been reviewed with the pt included bleeding and possible manufacturer defects.".

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick, nj
• Manufacturer (Section G): ARTEGRAFT, INC.; 206 north center drive; north brunswick, nj
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, nj ; 4228333
• MDR Report Key: 9793114
• MDR Text Key: 240622348
• Report Number: 2247686-2020-00001
• Device Sequence Number: 1
• Product Code: LXA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N16837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: AG840
• Device Catalogue Number: AG840
• Device Lot Number: 19D109-047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2019
• 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