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

Model Number 85397

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/14/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that following the release of the advanta v12 stent into the superior mesenteric artery, during the catheter retrieval maneuver and simultaneous advancement of the anl introducer (cook) inside the stent, a complete detachment of the catheter balloon occurred.

Event Description

N/a.

Manufacturer Narrative

The described procedure was the following as described in the complaint details.Endovascular exclusion of thoracoabdominal aneurysm with cook fenestrated aortic endoprosthesis.Following the release of the advanta stent into the superior mesenteric artery, during the catheter retrieval maneuver and simultaneous advancement of the anl introducer (cook) inside the stent, a complete detachment of the catheter balloon occurred.Based on the details of the complaint it is difficult to determine the root cause of the complaint as this advanta v12 was used in conjunction with a cook custom fenestrated aortic endograft.Many endografts including the cook fenestrated endografts have fixation barbs that anchor the endograft in the patient¿s aorta.In some cases, it is possible that the balloon can be punctured by one of the extremely sharp fixation barbs.If the balloon had ruptured during the procedure balloon deflation would have been difficult dependent of the size of the balloon tear or hole.Additional information received stated that the physician only allowed a few seconds for balloon deflation.The instructions for use (ifu) specify in the deployment section the following: "deflate the balloon by pulling vacuum on the inflation device to its maximum volume for 40 seconds.Verify full balloon deflation via fluoroscopy before proceeding to the next step".In this regard, it is very possible that the balloon was not fully deflated after only a few seconds and is the likely cause of the balloon being separated from the catheter.Based on the images provided it is difficult to determine the series of events but it is clear that the catheter shaft broke at the location of the proximal balloon weld.The balloon has become inverted and pushed down the catheter shaft and bunched up at the distal end of the introducer sheath, without the returned device, a full assessment of the condition of the device cannot be conducted.A full review of the device history records shows that this production lot of catheters passed all quality and performance criteria and there were no non-conformances noted during the manufacture of the product.Specifically the proximal balloon weld tensile test requirements.The data from the device history records shows that the minimum proximal weld tensile test value of the 13 samples tested was 22.35 newton¿s.The product requirement document for v12 otw vascular covered stent proximal weld tensile strength specifies that the minimum allowable proximal weld tensile strength is to be 15 newton¿s.The actual data exceeds this specification by 7 newtons.The review of the device history records also shows that the combined balloon burst test data of 47 samples shows that the minimum burst value was 20 atmospheres.The balloon burst requirement states that the system must not leak or burst below the rated burst pressure of 12 atm.This requirement for this lot of catheters has been exceeded by 7atm.The review also included the review of the drawn down catheter shaft assembly whereas the catheter shaft drawdown location is tensile tested to ensure the integrity of the drawdown inflection point.This is the location of the proximal balloon bond weld.The data shows that the drawn down extrusions met the requirement of 22.5 newtons.The actual minimum tensile test value was 42 newton¿s.The information provided clearly stated that the deflation time allowed by the physician to deflate the balloon was insufficient and that only a few seconds were allowed to deflate the balloon.The instructions for use specify the minimum of 40 seconds.Based on the details of the complaint and the images provided there is no evidence to conclude that the device was faulty.The product met all quality and performance requirements.H3 other text: not returned.

• 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: 11710924
• MDR Text Key: 250187764
• Report Number: 3011175548-2021-00422
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00065086285397
• UDI-Public: 0065086285397
• 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: 06/30/2021

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: 02/22/2024
• Device Model Number: 85397
• Device Catalogue Number: 85397
• Device Lot Number: 469320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 04/22/2021
• Supplement Dates Manufacturer Received: 06/27/2021
• Supplement Dates FDA Received: 06/30/2021
• Patient Sequence Number: 1
• Treatment: COOK ANL INTRODUCER
• Patient Age: 83 YR
• Patient Weight: 90