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

Device Problem Human-Device Interface Problem (2949)

Patient Problem Bacterial Infection (1735)

Event Type  Injury  

Event Description

A published literature article states that one immunosuppressed patient developed a vancomycin-resistant enterococcus graft (artegraft) infection and required removal 2 months following the initial procedure.A femoral-saphenous loop graft with bcag was placed.The patient presented 1 month postoperatively with a wound dehiscence, and would cultures revealed vancomycin-resistant enterococcus.The patient was treated with intravenous antibiotics, and a tensor fascia lata flap was performed for coverage in an attempt to salvage the access graft; however, a graft infection developed and surgical removal was required.A rectus abdominis rotation flap was used to cover the soft tissue defect in the groin following artegraft removal.Artegraft contacted the corresponding author for additional information (exact date, lot number) and current patient status but no response was received.

Manufacturer Narrative

Mdr for artegraft complaint number complaint - (b)(4) was submitted on (b)(4) 2015.Evaluation codes: method - the actual graft was not evaluated because it was not returned and no lot information was provided.Results - microbial contamination (vre) was determined from a culture of the wound.Conclusion - unable to confirm the complaint.The artegraft vascular graft was not returned for evaluation.Lot information was not provided and could not be obtained.However, infection is a known inherent risk of the graft implanting procedure.The complaint issue will be monitored and trended within artegraft, inc.Quality systems, quality assurance trending.

• Brand Name: ARTEGRAFT
• Type of Device: COLLAGEN VASCULAR GRAFT
• Manufacturer (Section D): ARTEGRAFT, INC.; 206 n. center dr.; north brunswick NJ 08902
• Manufacturer Contact: cynthia salter ; 206 north center dr.; north brunswick, NJ 08902 ; 7324228333
• MDR Report Key: 4486975
• MDR Text Key: 5327311
• Report Number: 2247686-2015-00001
• 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: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 55 YR