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

Model Number 85353

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Rupture (2208)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

On completion of the investigation a follow up report will be submitted.

Event Description

It was reported that the physician was performing an large complex juxta-renal aneurysm repair.The size stent required was not available so he used a larger size.This led to vessel rupture and bleeding resolved by urgent relining.

Manufacturer Narrative

Based on the details of the complaint the physician had planned to use an advanta v12 5mm x 22 mm covered stent on a patient with a large and complex juxta-renal aneurysm but discovered that the two devices he had in inventory were expired.The physician opted to try to use an advanta v12 6mm x 22mm stent.This decision to use a larger stent ultimately ruptured the renal artery.This rupture was repaired then by the use of a 7mm advanta v12 covered stent then a self-expanding stent of unknown origin.Based on the details of the complaint it is clear that the wrong size stent was used to stent the renal artery due to the lack of the 5mm x 22 size stent availability.Any procedure should be planned to ensure the proper materials are available for a successful result.Being that this was reported as a complex juxta-renal aneurysm case pre planning would include verification of materials and expiration dates of materials.The sizing section of the instructions for use states the following: "measure the inner diameter of the vessel to determine the appropriate diameter stent.The advanta v12 stent is labeled as the outer diameter".H3 other text : not available for return.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10599743
• MDR Text Key: 208997086
• Report Number: 3011175548-2020-01172
• 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,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 85353
• Device Catalogue Number: 85353
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR