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

Model Number 85364

Device Problem Material Deformation (2976)

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

Event Date 03/09/2022

Event Type  malfunction  

Event Description

It was reported that the advanta v12 10x38mm was introduced via 7f lock as part of an evar.It turned out that the stent that was selected was too short, therefore it was changed to a 10x59mm.The 10x38mm stent was removed without being inflated or deployed.Upon completion of the procedure the physician chose, for the purposes of demonstration to deploy the removed v12 10x38mm stent outside the patient.The physician observed tears in the eptfe cover.

Manufacturer Narrative

The follow-up report will be submitted upon completion of the investigation.

Manufacturer Narrative

Investigation: based on the details of the complaint the stent chosen (advanta v12 10x38 mm) was too short and removed from the patient and exchanged for a longer (advanta10x59mm).At the end of the surgery the unused 10x38mm covered stent delivery system was slowly insufflated to 6atm for the purpose of the demonstration until the stent was fully deployed.The eptfe cover of the stent tore in the center of the stent.Upon received the device back from the field the product was removed from the packaging and inspected.The stent was still on the balloon that was still filled with fluid and there was a 1.5cm long tear in the eptfe cover of the stent confirming the complaint.Although the tear in the cover has been confirmed, the tear in the cover is not a deficiency of the product design, process, material, operator, manufacture or equipment as the product was not designed to be deployed outside the vasculature or outside the patient.The eptfe cover to perform properly needs to be deployed at body temperature and within fluid and not on a bench outside the patient.Therefore, the root cause is determined to be user error.A review of the device history records going back to the sub assembly level where the eptfe cover was applied to the stent was conducted and there were no non-conformances noted and the product met all quality and performance requirements.Within the two device history records for the covered stents (dhr 463413 and 463414) a total of 13 stents of each lot are tested to ensure the integrity of the ptfe covering of the stent following manufacturing procedure tp009266 covered stent expansion test and visual aid va009011.All 26 total samples passed this expansion test requirement.During the performance testing of the production lot of covered stent delivery systems, an additional sampling of 20 stents were deployed to ensure the stents met the dimensional acceptance criteria.During this test the stent is expanded when the balloon is pressurized to 8atm as specified on the product label.When the stent opens the eptfe stent covering material is inspected to ensure it meets all visual requirements following visual aid deployed stent visual defect criteria va009011.Per the visual aid any hole in the cover that breaches both the inner and outer eptfe layers is rejected.There were no failures.The total amount of stents expansion tested to ensure the ptfe integrity was 46 samples in total without any rejects.The historical review did not identify any adverse trends.The review of ncrs and capas were able to rule out any related issues, given the identified root cause for this complaint being use error.There were no other complaints received for the affected lot.A risk review found that the risk management documents for this product adequately address the reported defect and the severity and anticipated occurrence level are appropriate.

Event Description

N/a.

• 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: 13896008
• MDR Text Key: 287918809
• Report Number: 3011175548-2022-00111
• 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: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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: 09/29/2023
• Device Model Number: 85364
• Device Catalogue Number: 85364
• Device Lot Number: 464897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 10/04/2022
• Supplement Dates FDA Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7F LOCK
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 71 KG