MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12 COVERED STENT; STENT, RENAL

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

Patient Problems Arrhythmia (1721); Thrombosis (2100)

Event Type  Injury  

Manufacturer Narrative

A complete investigation was not able to be performed as no product code, lot number or sample was provided.Per the study, endovascular repair and open repair of raa had similar favorable perioperative and midterm outcomes, but endovascular repair had shorter operative time, icu stay, hospitalization time and less estimated blood loss.

Event Description

Received an article titled "outcomes of endovascular treatment and open repair for renal artery aneurysms: a single center retrospective comparative analysis" published in the journal of vascular and interventional radiology.The article compares outcomes of endovascular repair and open repair in treatment of renal artery aneurysms (raas).Per the article adverse events included embolic events, thrombosis and arrhythmia.

• Brand Name: ADVANTA V12 COVERED STENT
• 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: 8116352
• MDR Text Key: 128859849
• Report Number: 3011175548-2018-01409
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/29/2018

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: 11/14/2018
• Initial Date FDA Received: 11/29/2018
• 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