MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION ADVANTA V12 COVERED STENT; PTFE COVERED STENT

Device Problem Failure to Advance (2524)

Patient Problem Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

Received an article titled "retrograde target vessel catheterization as a salvage procedure in fenestrated/branched endografting" published in the journal of endovascular therapy in 2015.The study consisted of retrograde target vessel catheterization as a bailout technique in fenestrated and branched endografting.The study involved 11 patients from 2003 through 2014 with juxtarenal, suprarenal, and thoracoabdominal aortic aneurysms that required retrograde target vessel access as a bailout measure due to failure of an antegrade approach.Per the study, one patient with left renal artery (lra) occlusion also suffered temporary renal function deterioration not requiring dialysis.

Manufacturer Narrative

(b)(4).A complete investigation was not able to be performed as no product code, lot number, or sample was provided.Per the study, it suggest that retrograde target vessel access is a feasible bailout procedure when antegrade cannulation fails.Secondary technical success is high, but the procedure is associated with higher perioperative morbidity and longer hospital stay.Related mdr's: 1219977-2015-00201, 1219977-2015-00203.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lori gosselin ; 5 wentworth drive; hudson, NH 03051-4929 ; 6038645366
• MDR Report Key: 4952180
• MDR Text Key: 6633508
• Report Number: 1219977-2015-00202
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/06/2015

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: 07/06/2015
• Initial Date FDA Received: 07/30/2015
• 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