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

Model Number 85365

Device Problem Positioning Problem (3009)

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

Event Date 11/05/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient had a thoraco-abdominal aneurysm.A cook fenestrated endograft was implanted.The physician tried to position the stent with a 7fr cook sheath into the celiac artery from a right femoral approach.The sheath and stent were difficult to position due to the angle of the celiac artery.The physician felt that he needed to apply force to advance the delivery catheter further.He decided to remove the stent device and the sheath from the patient.The catheter bent and broke.Another device was used to complete the procedure.

Manufacturer Narrative

The device in question was not returned making an assessment of the shaft breakage difficult.An image of the catheter balloon with the stent still crimped on the balloon was provided.The stent in the image has a slight curvature to it from navigating through the anatomy to the celiac artery.An image of the celiac artery location was provided by the institution that filed the complaint.The shaft in the images appears to have been broken in the middle of the proximal balloon bond.The proximal end of the broken shaft was not shown in the image to determine if the shaft had necked down to a smaller diameter while attempting to pull the catheter back through the introducer sheath.The stent in the image appeared to have no damage to it nor did the underlying balloon.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 including proximal balloon weld tensile testing.The proximal balloon bond tensile strength data was evaluated.Out of the 20 samples tensile tested the lowest break force seen was 23 newtons.The minimum break force allowed is 15 newtons.This lot of catheters passed the break force requirement.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 10 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.Distal tip tensile testing.Catheter leak check.Conclusion: based on the investigation details provided it appears as if the bend into the celiac artery with a femoral approach may have attributed to the catheter separation.The sheath when bent to such a degree can become slightly flattened or oval at the apex of the bend making advancement or removal difficult.Based on the details of the complaint atrium medical corporation cannot conclude that the device was at fault.Atrium medical has not tested or evaluated the v12 covered stent for use in the celiac artery.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8059540
• MDR Text Key: 127080476
• Report Number: 3011175548-2018-01274
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

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: 07/19/2021
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 433884
• Was Device Available for Evaluation?: No
• Device Age: YR
• Initial Date Manufacturer Received: 11/05/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 11/15/2018
• Supplement Dates FDA Received: 11/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR