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

Model Number 85390

Device Problem Material Separation (1562)

Patient Problem No Information (3190)

Event Date 11/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that after deploying the stent in the celiac artery the physician attempted to remove the balloon catheter.The balloon separated from the catheter during withdrawal.

Manufacturer Narrative

Analysis: a review of the complaint details has been conducted.The details indicate that the balloon separated from the catheter shaft while stenting the celiac artery as part of an endovascular aortic aneurysm repair procedure (evar).The details also state that the separation of the balloon occurred under normal tensile conditions.An explanation of what normal tensile conditions are was not provided with the details.The response received was that ¿no excessive force was used¿.Also provided with the complaint were fluoroscopic images of the procedure.The images provided show the amount of difficulty tracking through multiple endografts to reach the intended target of the celiac artery.It is clear that the advanta v12 was protected by the introducer sheath during advancement to the celiac artery; however none of the images provided show the deflation or withdrawal of the device back into the introducer sheath.Within the images the advanta v12 stent is shown in place at a very acute angle off of the straights of the aorta however the landing zone of the stent is in the same vicinity of the fixation barbs of the aortic endograft.The returned product received contained the separated balloon and catheter shaft, an 0.035 cordis emerald green guidewire and a cook check-flo performer introducer sheath.The balloon was separated from the catheter shaft at the proximal balloon thermal weld.The balloon had been bunched up specifically at the distal end of the balloon.The distal balloon thermal weld was still fully intact.The proximal inflation lumen hole (skive) was distorted and damaged.This is one of two skives where the contrast media enters the balloon to inflate the balloon and deploy the stent.The distal skive hole was normal.The catheter shaft had been stretched to a smaller diameter as the shaft necked down prior to breaking at the proximal balloon thermal weld.The distal balloon cone of the balloon contained a large amount of bodily fluid indicating that the balloon may have not been evacuated fully prior to removal back through the introducer sheath.As the balloon was separated at the balloon bond verifying if the was a pinhole or other damage to the balloon was not able to be determined.The introducer sheath used in the case was in very poor condition.The tip of the sheath was prolapsed on one side and compressed due to the force applied to the catheter.There was also a large accordion like defect in the sheath approximately 10cm from the distal tip of the sheath.The apex of the pre-set curve of the introducer was also compressed upon itself.The details provided do indicate that two other devices were passed through the introducer sheath prior to the use of the advanta v12 covered stent.Based on the condition of the sheath it is very evident that a great amount of force was applied to sheath during removal of the advanta v12 covered stent delivery system to cause this type of damage to the sheath.A full review of the device history records indicates that this lot of advanta v12 covered stent delivery systems passed all quality and performance requirements.The balloon bond tensile strength of every lot manufactured is tested to ensure the integrity of the balloon bonding process.The device history records show that the lowest bond strength realized was 27.4 newtons (n).The minimum requirement is 10 n.The proximal balloon weld tensile requirement was exceeded by over 10 n.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 (7fr).¿ 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).¿ stent retention testing.Stent must have retention = 5.5n for 7fr introducer sheath/guide.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 (minimum tensile strength = 10n) ¿ distal tip tensile testing.¿ catheter leak check.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Conclusion: based on the review of the complaint details, fluoroscopic images, physical product evaluation and the device history records review atrium medical cannot conclude that there was an issue with the product in question.

Event Description

N/a.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 9373706
• MDR Text Key: 175192981
• Report Number: 3011175548-2019-01203
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

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: 08/21/2022
• Device Model Number: 85390
• Device Catalogue Number: 85390
• Device Lot Number: 450190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Initial Date Manufacturer Received: 11/18/2019
• Initial Date FDA Received: 11/25/2019
• Supplement Dates Manufacturer Received: 01/13/2020
• Supplement Dates FDA Received: 01/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Weight: 80