MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION VXT VASCULAR GRAFT

Device Problem Insufficient Information (3190)

Patient Problem Fluid Discharge (2686)

Event Type  Injury  

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.Related mdr reports: 1219977-2016-00107, 1219977-2016-00108, 1219977-2016-00109, 1219977-2016-00110, 1219977-2016-00111.

Event Description

Report received indicates that the implanted graft exhibited weeping the entire length of the graft several days after the procedure.

Manufacturer Narrative

The lot number was not provided so a device history record could not be performed and the graft was not returned therefore the root cause could not be identified.Several attempts were made to obtain additional information regarding the complaint and the complainant provided no additional details except that no further surgery was needed following the event and the graft still remains implanted in the patient.All graft lots undergo inspection and testing prior to release per internal quality procedures.The inspection and testing includes the following: longitudinal tensile strength, radial tensile strength, water entry pressure, suture retention, 100% visual and tactile inspection.All testing requirements are reviewed and verified prior to releasing the graft lots.Peri-graft seroma is defined as a sterile collection of fluid confined within a non-secretory fibrous pseudo-membrane surrounding a vascular graft.The instructions for use advise to properly size the tunneler instruments to prevent peri-graft seroma formation.It also warns against applying excessive tension to the anastomosis.The instructions for use list weeping/seroma as an adverse reaction.

• Brand Name: VXT VASCULAR GRAFT
• Type of Device: VXT VASCULAR
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH 03054 ; 6038645366
• MDR Report Key: 5752667
• MDR Text Key: 48300942
• Report Number: 1219977-2016-00138
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/19/2016
• Was Device Evaluated by Manufacturer?: No
• 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