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 Hemorrhage/Bleeding (1888); Rupture (2208); Pseudoaneurysm (2605)

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 article endovascular treatment using either covered stents or embolization techniques is an effective and safe emergency therapy for life-threatening postpancreatectomy hemorrhage with good clinical success rates and long-term results.[(b)(4)].

Event Description

Received an article: hassold, n.E.(2016).Effectiveness and outcome of endovascular therapy for late onset postpancreatectomy hemorrhage using covered stents and embolization.Journal of vascular surgery, 1373-1383.Purpose: to evaluate the clinical and long-term outcome of patients who underwent covered stent treatment because of late-onset postpancreatectomy hemorrhage in a greater number of patients.Per the article adverse events included rupture of pseudoaneurysm during intervention.

• 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: 7948067
• MDR Text Key: 123121363
• Report Number: 3011175548-2018-01134
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 09/24/2018
• 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
• Patient Age: 63 YR