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

Model Number 85338

Device Problems Unintended Movement (3026); Activation Failure (3270)

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

Event Date 07/11/2023

Event Type  malfunction  

Manufacturer Narrative

Upon completion of the investigation into this event a follow up report will be submitted.

Event Description

During a procedure, at the time of deployment of the stent, the balloon does not inflate midline and the stent does not attach.It migrates upon removal of the delivery catheter.The stent was attached with a balloon and a second stent was laid.

Event Description

N/a.

Manufacturer Narrative

Additional information: section d9 & h6 investigation: this complaint reports a possible balloon leak.The user attempted to place an advanta v12 covered stent (p/n 85338) along with another v12 stent to treat stenosis of the aortic bifurcation of the two iliac arteries.The user reported that the balloon would not inflate at the midline so they could not attach the stent.They also stated that the stent deployment system "migrated" when the delivery catheter (terumo) was removed.The user provided pictures of the balloon (the stent was not present) which show blood inside the balloon which is indicative of the presence of a hole.The balloon also appears as if it partially inflated on both ends but not in the middle, as evidenced by how narrow it is in the middle and how it flares out on the ends.The ends appear as if they were inflated and then deflated while the middle was never inflated.The device was returned for evaluation.The balloon was inflated up to 10 atm.It did expand in the middle, but a leak was identified in the proximal transition zone of the balloon, just above the proximal ro marker.Pictures were taken of the hole under a microscope (attached).The hole appears similar to some identified previously in ncrs for pinholes found in this region of balloons.The most likely causes of those past cases were determined to be crimping or handling of the balloon and potential contact with blades, equipment, burrs, or inspection fixtures.The flow rate of the leak was measured at 1.57 slpm.A dhr review of the finished good and relevant subassemblies was completed.No evidence was identified to suggest a specific manufacturing step or equipment are the cause of this complaint, however it cannot be ruled out that the damage may have occurred during manufacturing.No evidence was identified to suggest materials, or any design changes of the device or relevant subassembly parts are related to this complaint.The ifu provides adequate instructions and warnings for proper use of the device and no evidence was identified to suggest it is related to this complaint.Based on the provided pictures, the complaint and the device nonconformity are confirmed.While a specific process step in manufacturing was not identified as the cause, the damage to the returned device resembles that which has been previously seen in manufacturing.For that reason, the root-cause of this complaint is manufacturing - assembly.The hazardous situation/harm is addressed in the harm hazards analysis document which assigns it a severity level of 3.This was determined to be appropriate based on the harm that was reported in the complaint.Complaint trending concluded that the actual occurrence level did not exceed the anticipated occurrence level.No evidence was identified to suggest that this complaint is related to design, materials, or instructions for use.Manufacturing has been a known cause for this type of failure and the pictures taken of the returned device resemble the damage seen previously during manufacturing.Additionally, the leak rate of this pinhole is much higher than what has been seen previously.For this reason, this investigation has been escalated to a capa request (cr 899850).The complaint meets the escalation criteria of a confirmed complaint with most likely root cause as manufacturing.

Event Description

During a procedure for iliac aorto stenosis, when deploying the stent, the balloon does not inflate midline and the stent does not attach.It migrates upon removal of the delivery catheter.The stent was fixed with a balloon and a second stent was placed.

Manufacturer Narrative

Additional information: sections a1, a2, a3, a4, b5, b7 & d10.Corrected information: section h6.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH
• Manufacturer Contact: lori gosselin ; 40 continental blvd; merrimack, NH
• MDR Report Key: 17360669
• MDR Text Key: 319481030
• Report Number: 3011175548-2023-00154
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2023

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 Model Number: 85338
• Device Catalogue Number: 85338
• Device Lot Number: 490845
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 07/21/2023; 09/27/2023
• Supplement Dates FDA Received: 07/21/2023; 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TERUMO GUIDE WIRE
• Patient Age: 90 YR
• Patient Sex: Female
• Patient Weight: 85 KG