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

Device Problems Leak/Splash (1354); Occlusion Within Device (1423); Human Factors Issue (2948)

Patient Problem Thrombosis (2100)

Event Date 04/13/2017

Event Type  Injury  

Manufacturer Narrative

The complaint artegraft (collagen vascular graft) was returned to artegraft, inc.For evaluation.Visual evaluation of the returned graft verified that the graft had been cut into 3 segments and a black suture was visible on one of the smaller graft segment ends.The customer's allegation of leaking graft pre-implant and thrombosed/"white clot" during the implant procedure were not able to be confirmed.A review of the production batch records was not able to be conducted as graft lot and product code were not provided (multiple attempts were made to retrieve the information).Possible root causes for the leaking graft pre-implant may be that a ligation suture on the graft tributary loosened or too much force may have applied during the pre-implant pressure test.No additional information is available regarding the tools/methods utilized by the customer for pressure testing for this incident.As this is a known issue, artegraft, inc.Instructions for use include instructions for pressure testing each graft prior to implant.Capa was previously initiated to investigate similar occurrences involving graft wall leaks pre-implant.Additional quarterly analysis of the grafts was implemented for post-sterilization data and trending.No complaint trend was identified related to thrombosis.Possible root cause for the thrombosis and "white clot" was stated by the implanting surgeon that she did not believe the graft caused any of the issues but rather the patient's hypotension with the use of pressors without the use of heparin.With the second artegraft, without pressors and with heparin, the implant was successful.Thrombosis is a known adverse reaction and is discussed in the 'warnings' section of the artegraft instructions for use, ls 012 rev.M.The complaint issues will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Should additional information become available, a follow-up report will be submitted.

Event Description

Artegraft inc.Received an email communication that an artegraft (collagen vascular graft) was implanted and then explanted.In follow-up conversations with the implanting surgeon from the hospital it was explained that "when i first flushed the graft, there was a small leak at one end.I opted to trim this section and use the remainder of the graft.It was a distal brachial artery to proximal brachial vein graft.Initially, the graft had a good thrill.I opted to band the graft due to augmentation of distal signals.By the time, i completed the banding, the graft was completely thrombosed.Other factors at play were hypotension requiring pressors, and heparin was not given prior to the anastomosis.Of note, the entire graft was filled with "white" clot.Once i cleared clot from the artery, gave heparin and ask anesthesia to avoid pressors, we created a new access with a new artegraft.This was successful." artegraft scientific advisor, spoke with the implanting surgeon to discuss the details related to this incident.The surgeon stated that she did not believe the graft caused any of the issues but rather the patient's hypotension with the use of pressors without the use of heparin.With the second artegraft, without pressors and with heparin, the implant was successful.The complaint graft was returned to artegraft inc for evaluation.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT,INC.; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer (Section G): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902 4247
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902-4247 ; 7324228333
• MDR Report Key: 6571928
• MDR Text Key: 75331314
• Report Number: 2247686-2017-00004
• 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: company representative,distri
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: PRESSORS
• Patient Outcome(s): Congenital Anomaly; Required Intervention
• Patient Age: 23 YR
• Patient Weight: 62