MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 VASCULAR STENTS; STENT, ILLIAC

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Aneurysm (1708); Ischemia (1942); Rupture (2208); Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.The article concluded that the endovascular repair of taaa by using cook zenith fenestrated/branched endografts is feasible with acceptable technical and clinical results at early to mid-term results in patients at high surgical risk unfit for or.

Event Description

Article received: gallitto, e.E.(2017).Endovascular repair of thoracoabdominal aortic aneurysm in high surgical risk patients: fenestrated and branched patients.Annals of vascular surgery, 170-177.Purpose:to report early and mid-term results of endovascular repair of thoracoabdominal aortic aneurysms (taaa) by using cook zenith fenestrated/branched endograftes (fb-evar) in high surgical risk patients unfit for open repair.Per the article adverse events included: iliac rupture, blood loss requiring transfusion, spinal cord ischemia, endoleaks, cardiac and pulmonary complications, renal occlusion.

• Brand Name: ADVANTA V12 VASCULAR STENTS
• Type of Device: STENT, ILLIAC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7921912
• MDR Text Key: 122171881
• Report Number: 3011175548-2018-01073
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• 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
• Report Date: 10/01/2018

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: 09/14/2018
• Initial Date FDA Received: 10/01/2018
• 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