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

Model Number 85387

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

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, percutaneous retrieval of a lost stent during transcatheter intervention is safe and efficacious in the treatment of ac.

Event Description

Received an article titled successful retrieval of a lost stent in a middle-aged woman with unnoticed native aortic coarctation published in the international journal of cardiology.The article reported a complicated case with a lost stent, which was then subsequently successfully retrieved during the same intervention.Per the article, adverse events included migration off balloon.

Manufacturer Narrative

A full review of the device history records was conducted.The review indicates that this lot of advanta v12 covered stents met all quality and performance criteria.There were no non-conformances related to the complaint.[(b)(4)].

Event Description

The physician response: "the stent might have proximally slipped due to several reasons discussed in the article.

• Brand Name: ADVANTA V12 LD
• Type of Device: STENT, ILLIAC
• 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: 8180571
• MDR Text Key: 130910739
• Report Number: 3011175548-2018-01507
• Device Sequence Number: 1
• Product Code: NIO
• 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,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: 85387
• Device Catalogue Number: 85387
• Device Lot Number: 10812913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/08/2011
• 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 Weight: 60