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

Device Problem Premature Activation (1484)

Patient Problem No Information (3190)

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, control of bleeding was achieved in all patients who underwent stent graft implantation for treatment of access site vascular complications.

Event Description

Received an study titled "outcome of stent graft implantation for treatment of access site bleeding after transfemoral transcatheter aortic valve replacement." the study was to evaluate the immediate outcome of stent graft implantation for control of access site bleeding and the need for repeat vascular interventions after stenting.A cohort of 34 consecutive patients with severe symptomatic aortic stenosis who underwent transfemoral tavr from march 2010 to march 2015.Per the study adverse events occurred of unintended deployment and a minor complication of a inadvertently deployed stent.

• Brand Name: ADVANTA V12
• 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: 7339898
• MDR Text Key: 102437598
• Report Number: 3011175548-2018-00255
• 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: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2018
• 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: 02/26/2018
• 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): Required Intervention