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

Model Number AG715

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

Batch record review was performed; the batch met all criteria, including pressure testing, sterility testing, and final visual inspection upon release.The patient status was reported as stable.A previous capa ((b)(4)) was initiated for graft leakage.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Device was discarded by the physician.

Event Description

Artegraft inc.Received an email communication from an authorized distributor that an artegraft (collagen vascular graft) was identified as leaking and explanted.Upon follow-up communications with the physician, it was stated that the graft was pressure tested and flushed per the artegraft ifu.After tunneling the graft began "leaking" and was not able to be used "was never sewed in" (i.E.Anastomic connection).The physician reported that it appeared that there were multiple small leaks from the side walls of the graft.This primary graft was intended to be implanted in the patient's upper arm.As a result, an alternate ptfe graft was implanted and the patient is reported in stable condition.Some conflicting details were initially provided from the distributor such as the physician did not remember pressure testing prior to implanting but tested it after the graft was removed from the patient.It was stated that the physician stitched the venous end first and "filled it up" and saw "oozing".The artegraft was disposed of via medical waste at the hospital and the product was not available for artegraft review.

• 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: 5144139
• MDR Text Key: 28044841
• Report Number: 2247686-2015-00007
• 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: distributor,health profession
• Reporter Occupation: Physician
• Report Date: 09/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2017
• Device Model Number: AG715
• Device Catalogue Number: AG715
• Device Lot Number: 14G186-013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/08/2014
• 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
• Patient Age: 85 YR
• Patient Weight: 52