MAUDE Adverse Event Report: ATRIUM MEDICAL CORP ADVANTA VS GRAFT; PROTHESIS, VASCULAR GRAFT

Device Problem Torn Material (3024)

Patient Problem No Code Available (3191)

Event Date 06/10/2014

Event Type  Injury  

Event Description

Doctor did an axillo femoral bypass with a ringed graft.The pt was brought back to the hospital for a torn proximal anastomosis.Pt was stented.When the graft was removed, it showed an intact anastomosis on the subclavian vessel and a shredded anastomosis on the graft.

Manufacturer Narrative

We are in the process of performing the investigation and will submit the follow-up report once the evaluation is completed.

• Brand Name: ADVANTA VS GRAFT
• Type of Device: PROTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORP; hudson NH 03051
• Manufacturer Contact: theresa morin ; 5 wentworth dr.; hudson, NH 03051 ; 6038645237
• MDR Report Key: 3946585
• MDR Text Key: 4645461
• Report Number: 1219977-2014-00213
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K992443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/16/2014

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: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/16/2014
• Initial Date FDA Received: 07/14/2014
• 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?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 88