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

Model Number 85345

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/23/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after opening the packaging, it was visible that the stent was not lying correctly on the balloon and the stent was sticking out at the front.The stent was not implanted.

Event Description

N/a.

Event Description

N/a.

Manufacturer Narrative

Based on the details provided the stent of the 7mm x 22mm advanta v12 had been found loose after removing it from the packaging.The stent had been reported to be loose on the balloon and sticking out.Upon inspection of the returned device, it was obvious that the device had been within the vasculature as the stent was blood stained and deformed.The stent was loose on the balloon but was still within the ro marker bands.The stent had a large curve to it from navigating the vasculature.Based on the details and the condition of the received product the product had been placed in the vasculature and removed for reasons not provided.The deformation of the stent and angulation of the bend within the stent is characteristic of attempting to make a very tight turn in the vasculature.A review of the device history records (dhr) indicates that this lot of 7mm x 22mm advanta v12 catheters passed all quality and performance requirements.There were no non-conformances noted during the manufacture of the device.A review of the stent retention data within the dhr shows that the minimum stent retention (dislodgement force) was 9.5 newtons.The requirement for stent retention out of the box as defined in product requirement document is 5.5 newtons.The investigation was not able to confirm the complaint as the stent was claimed to have been loose as it was removed from the packaging and not used.The returned device had been used and inserted into the vasculature of the patient and had most likely been damaged during this process.

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
• MDR Report Key: 11735390
• MDR Text Key: 250184772
• Report Number: 3011175548-2021-00458
• 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,Followup,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/23/2023
• Device Model Number: 85345
• Device Catalogue Number: 85345
• Device Lot Number: 461727
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2021
• Initial Date Manufacturer Received: 04/23/2021
• Initial Date FDA Received: 04/27/2021
• Supplement Dates Manufacturer Received: 05/17/2021; 05/27/2021; 07/19/2021
• Supplement Dates FDA Received: 05/17/2021; 06/15/2021; 08/16/2021
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Weight: 75