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

Device Problems Collapse (1099); Fracture (1260)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Received an article titled early and late outcome of covered and non-covered stents in the treatment of coarctation of aorta - a single centre experience.Purpose: stenting of coarctation of aorta with covered or uncovered stents is the accepted modality of treatment in older children and adults.We attempted to study the early and late outcomes after stenting of native and recurrent coarctation of aorta with uncovered and covered stents.Method: this is a retrospective study of patients who underwent stenting for coarctation of aorta with covered or non-covered stents at our institute.Early and late outcome for both the groups were studied.Per the article product malfunctions occurred including strut fracture and stent collapse.

Manufacturer Narrative

Based on the details provided within the article it was reported that one stent had a strut fracture and a stent collapse.Per the article the stents were deployed as part of a study for coarctations of the aorta.The advanta v12 covered stent system is indicated for restoring and improving the patency of the iliac and renal arteries.The product part number or lot number was not provided within the article and no responses to the request for additional information, therefore a review of the device history records could not be conducted.Without more detailed information regarding the stent fracture and claim of stent collapse the event within the study cannot be confirmed.Product lot numbers were not provided and no images of the procedure in order to aid in the investigation.All stents upon receipt go through an incoming inspection process to ensure the quality of the stent prior to release to manufacturing.Per the part specification drawing the following are inspected to ensure the integrity of the stent.¿ yield stress properties of the stent.¿ ultimate tensile strength of the stent.¿ elongation of the stent.All stent dimensions are measured including wall thickness at multiple locations.This is conducted by the manufacturer of the stent and verified by the atrium quality incoming inspection.There is no evidence to conclude that the advanta v12 covered stents were at fault.The use of the v12 stent is not indicated for use in coarctations of the aorta.H3 other text : product not available.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 10671393
• MDR Text Key: 213010814
• Report Number: 3011175548-2020-01222
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1