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

Model Number 85334

Device Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)

Patient Problem No Code Available (3191)

Event Date 10/24/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The v12 was positioned inside a 7fr sheath, and sitting in the renal artery.The endurant graft was deployed, and then v12 was unsheathed and deployed.The v12 balloon was left in the sheath in the aorta, whilst the endurant limbs were deployed.The v12 balloon was then positioned back into the v12.On pulling a negative on the inflation device it was noted that the balloon had a hole (blood back into the inflation device).It was attempted to retrieve the stent through the sheath, however there was resistance, so a decision was made to withdraw the sheath and stent catheter together.However when the balloon was trying to be pulled back through the skin, the balloon material bunched up in the artery.An arteriotomy was performed and the stent catheter and damaged balloon was removed.A 9fr sheath followed by a long 7fr sheath were then placed into the arteriotomy in the brachial artery, and delivered into the renal artery.Attempted ballooning with an abbott 7x40mm, however this balloon was also damaged.Post dilation was achieved with a 7x40mm balloon placed wholly inside the v12 stent, therefore protected from any barbs or hooks on the endurant.Patient stable but required arteriotomy in the brachial artery.The arteriotomy was closed without the need for a patch.Surgeon believes there was a rogue hook or barb from the evar graft that tore the balloon.

Manufacturer Narrative

Analysis: the device in question was returned and evaluated to determine the cause of the complaint.On opening the returned device packaging there were two catheters noted.There was the 7mmx38mmx120cm v12 covered stent delivery system that was still within the introducer sheath and an abbott 7x40mm balloon catheter.The v12 balloon had been ruptured at some point during the procedure.The balloon had a complete circumferential tear in the proximal balloon cone.A circumferential tear of this nature is indicative of a balloon that was punctured.The balloon of the v12 catheter was specifically designed to fail with a longitudinal tear so as in the unfortunate case the balloon does fail due to exceeding the rated burst pressure, upon removal back through the sheath any fluid is easily removed as the balloon is withdrawn back through the introducer sheath.The returned sheath was evaluated and inspected for any damage.No damage was noted.The returned abbott laboratories 7x40mm catheter that was returned to atrium medical corporation was also evaluated.The balloon was ruptured in relatively the same area with equally catastrophic balloon rupture that was circumferential to longitudinal creating a large flap of balloon material.As the details provided indicate the balloon of the v12 catheter and the abbott laboratories catheter were believed to have been punctured by one of the fixation barbs of the endurant endograft.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 balloon burst pressure testing.The burst testing was conducted on 49 individual balloons.The lowest burst pressure documented during this performance testing was 20.8atm.The labeled rated burst pressure for the v12- 7mm x 40mm balloon is 12atm.The balloon burst pressures are well above the 12atm 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 and the complaint details provided, ¿surgeon believes there was a rogue hook or barb from the evar graft that tore the balloon¿, it is very likely that the balloon on both the v12 covered stent delivery system and abbott laboratories catheter were punctured by the fixation barbs of the endurant endograft.Atrium medical corporation cannot conclude that the catheter in question was faulty.

Event Description

N/a.

• 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: 8056053
• MDR Text Key: 129046558
• Report Number: 3011175548-2018-01273
• 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: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Model Number: 85334
• Device Catalogue Number: 85334
• Device Lot Number: 426902
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK ENDURANT ENDOGRAFT; COOK ENDURANT ENDOGRAFT
• Patient Outcome(s): Required Intervention