MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA SST BIFURCATED GRAFT; PROSTHESIS, VASCULAR GRAFT

Model Number 24001

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Date 11/12/2014

Event Type  Injury  

Event Description

The physician attempted to use a bifurcated graft in an abdominal aortic aneurysm (aaa) repair case.The graft was not used after being cut to size because the internal rings extend too far for this specific use that the surgeon intended to do (the intent was to suture the right renal artery and superior mesenteric artery (sma) to the limbs and the main body was to be attached to gores 16x30mm eptfe stretch graft that was sutured in the abdominal aorta with involvement of both renal and sma).

Manufacturer Narrative

We are awaiting the return of the device for investigation and will submit the follow-up report once the evaluation is completed.

• Brand Name: ADVANTA SST BIFURCATED GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: lori gosselin, sr. specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 4275873
• MDR Text Key: 5032525
• Report Number: 1219977-2014-00386
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2016
• Device Model Number: 24001
• Device Catalogue Number: 24001
• Device Lot Number: AK09006
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2011
• 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
• Treatment: GORE 12X6MM BIFURCATED GRAFT; GORE 16MMX30CM STRETCH GRAFT
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Weight: 54