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

Model Number 85353

Device Problem Failure to Advance (2524)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician attempted to run the stent over an 0.035" amplatz wire.It would only advance approx 5 cm and stop.He exchanged for a terumo hydrophilic wire but the same occurred.While trying to advance over the wire the stent moved on the balloon.

Manufacturer Narrative

Based on the details of the complaint the.035 guide wire would not pass through the catheter.Upon reviewing the returned device a new.035 cordis emerald green guide wire was obtained.The lumen was flushed with water and the guide wire advanced into the distal tip of the catheter.The guide wire during advancement passed cleanly through both the distal and proximal radio opaque marker bands and met some minor resistance while passing through the proximal balloon area.The guide wire was able to be passed through the balloon and to a point in the catheter where the extrusion itself had been damaged approximately 30cm from the distal tip of the catheter.The damage to the shaft appears to be from pushing the catheter.The stent as described in the complaint details had been dislodged.Based on the details the stent was dislodged while trying to advance the guide wire inside the catheter.As the wire was able to be passed through the catheter the complaint cannot be confirmed.During the process of manufacturing there are two 100% inspections where a.035 guide wire is passed through the entire length of the catheter ensuring lumen patency.There are also other operations prior to these inspections where a.035 mandrel or larger is used during processing.The first operation where a guide wire is advanced through the entire length of the catheter is at the manifold bonding process.The manufacturing procedure ¿balloon catheter leak test, balloon od verification, otw stent delivery¿ section 5.4.4 states to insert a 0.035¿ guide wire through the manifold guide wire port until about one inch protrudes from the manifold.Ensure the guide wire has exited the distal tip.The second 100% inspection is conducted at the manufacturing final inspection following manufacturing procedure ¿manufacturing final inspection, crimped stent delivery¿ the procedures states in section 5.2.3 step 4 states place a device onto the table, then insert a 0.035¿ guide wire through the manifold guide wire lumen.Pass guide wire through entire length of the catheter shaft, removing it from the distal tip.Step 5 states reject any device which the guide wire could not be removed at the distal tip of the catheter.Remove the guide wire, then cutoff the manifold immediately.Place rejected device (both pieces) into a reject bag.A review of the device history records did not identify any non-conformances or rejects at either of the 100% inspections as all rejected samples are tracked and trended.As there are two 100% inspections in the process of manufacturing ensuring lumen patency the likelihood of a non-conforming part being released is extremely small especially where the device if found to be non-conforming during the process of manufacturing is physically destroyed at the time of inspection by cutting off the manifold of the catheter making the device non-functional.Based on the details of the complaint and investigation of the physical product, it is not clear why the physician had such great difficulty passing the guide wire through the catheter.

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: 11061308
• MDR Text Key: 223801180
• Report Number: 3011175548-2020-01498
• 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
• Report Date: 09/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/11/2023
• Device Model Number: 85353
• Device Catalogue Number: 85353
• Device Lot Number: 464235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Date Manufacturer Received: 08/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 0.035" AMPLATZ WIRE TERUMO HYDROPHILIC WIRE
• Patient Age: 83 YR