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

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

Patient Problems Embolus (1830); Hematoma (1884); Ischemia (1942); Thrombosis (2100); Stenosis (2263)

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 this case series demonstrates that treatment of complex aortoiliac occlusive disease with covered balloon expandable stents can have acceptable results with good patency and good clinical outcome.[(b)(4)].

Event Description

Article: tewksbury, r.E.(2015).Outcomes of covered expandable stents for the treatment of tasc d aorto-iliac occlusive lesions.Vascular, 1-7.Purpose: to report experiences with covered balloon expandable stents for treatment of tasc d lesions of the abdominal aorta and common iliac arteries.Per the article adverse events included: thrombosis, embolic events, ischemia, hematoma and restenosis.

• Brand Name: ADVANTA V12 VASCULAAR 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: 7942813
• MDR Text Key: 123049713
• Report Number: 3011175548-2018-01127
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• 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: 09/26/2018
• 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