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

Model Number 85338

Device Problems Break (1069); Difficult to Remove (1528); Detachment of Device or Device Component (2907); Physical Resistance/Sticking (4012)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the procedure was a 4 fenestration endovascular aneurysm repair (fevar).The stent was deployed successfully and the balloon was emptied.The clinician had difficulty withdrawing the catheter.Several attempts were made but the balloon was stuck.During the attempt to withdraw the hub broke loose from the catheter.

Manufacturer Narrative

Analysis: the v12 covered stent delivery system was removed from the package and inspected.The inflation manifold had been completely separated from the catheter shaft.The location of the catheter shaft break was inside the manifold.The adhesive bond was fully intact.The shaft leading up to the break had been necked down to a smaller diameter due to the force applied during the attempted removal through the introducer sheath.The balloon of the delivery system had a very large curve presumably from trying to navigate into and out of the superior mesenteric artery as the angulation into the artery is very tight.The stent in the case had been successfully deployed.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of v12 covered stent systems is tested to.This inspection requires that the catheter lot must pass the following: ¿ ability of the stent and delivery system to be passed through the labeled introducer sheath (6fr/7fr) depending on size.¿ ability to deploy the stent at nominal pressure (8atm).¿ ability to withdraw the deflated balloon catheter back through the labeled introducer sheath.¿ ability of the delivery system to withstand 5 inflate/deflate cycles at the rated burst pressure (12atm) without leaks or failures.¿ balloon burst testing.The balloon must burst over the rated burst pressure specified on the label (12atm).In addition to the final lot qualification testing there are multiple in-process inspections conducted that include the following: ¿ balloon hole skive dimensional verification.¿ stent securement testing.¿ proximal balloon weld tensile testing as detailed above.¿ distal tip tensile testing.¿ catheter leak check.A review of the manifold to shaft historical tensile test data indicates that the force required to separate the catheter shaft from the hub is on average 34 newtons (n).The requirement is a minimum of 15 n.This far exceeds the requirement.Conclusion: based on the investigation atrium medical corporation cannot conclude that the device was faulty.It is likely that the balloon had difficulty coming back into the sheath at such an acute angle in the superior mesenteric artery.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8482523
• MDR Text Key: 141174642
• Report Number: 3011175548-2019-00362
• Device Sequence Number: 1
• Product Code: NIN
• 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: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2021
• Device Model Number: 85338
• Device Catalogue Number: 85338
• Device Lot Number: 431778
• Device Age: YR
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/04/2019
• Supplement Dates Manufacturer Received: 05/10/2019
• Supplement Dates FDA Received: 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: INTRODUCER COOK, MEDTRONIC TOUR GUIDE, ROSEN WIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR
• Patient Weight: 80