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

Model Number AG630

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/23/2015

Event Type  malfunction  

Manufacturer Narrative

Batch record review was performed.The batch met all criteria and passed pressure testing and final visual inspection upon release.At the time of release, the wall thickness for this graft was documented within the acceptable parameter.Of the 30 grafts released in this batch, no additional complaints were reported to date.A previous capa ((b)(4)) was initiated.The complaint issue will continue to be monitored within artegraft, inc.Quality systems, quality assurance trending.Device was implanted.

Event Description

As reported by an authorized distributor, the surgeon stated that a collagen vascular graft [artegraft] had very thin walls and had "lots of suture hole leaks".The graft was pressure tested without issue as recommended in the artegraft ifu prior to the implant procedure.However, bleeding was observed at the suture line after the surgeon had completed suturing the anastomosis and after the clamps were removed.Bleeding stopped by use of a hemostatic agent and the graft was left in the patient.The patient is expected to dialyze without incident with this graft.6-0 prolene suture was used for the procedure.The type of needle used was requested but not provided.No additional observations regarding the graft were reported.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 north center drive; north brunswick NJ 08902
• Manufacturer (Section G): ARTEGRAFT, INC; 206 north center drive; north brunswick NJ 08902
• Manufacturer Contact: cynthia salter ; 206 north center drive; north brunswick, NJ 08902 ; 7324228333
• MDR Report Key: 4932985
• MDR Text Key: 22720058
• Report Number: 2247686-2015-00005
• 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: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: AG630
• Device Catalogue Number: AG630
• Device Lot Number: 15C062-028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2015
• 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: 61 YR