MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 LARGE DIAMETER STENTS; STENT, RENAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Type  Death  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.The use of ptfe covered stents for the treatment of isolated infrarenal aortic occlusive disease is safe and very effective.

Event Description

Received an article titled "polytetrafluoroethylene covered stent placement for focal occlusive disease of the infrarenal aorta".The purpose of the article was to evaluate the feasibility and efficacy of polytetrafluoroethylene (ptfe) covered balloon expandable stents.Per the article deaths occurred during the follow up period of unrelated causes.

• Brand Name: ADVANTA V12 LARGE DIAMETER STENTS
• Type of Device: STENT, RENAL
• 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: 7538345
• MDR Text Key: 109060688
• Report Number: 3011175548-2018-00510
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• 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
• Date Manufacturer Received: 05/01/2018
• 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): Death