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

Model Number 85361

Device Problem Retraction Problem (1536)

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

Event Date 06/22/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

After deploying the stent, the balloon could not be withdrawn from the distal end of the 7f introducer.No injury or consequence were reported.

Event Description

N/a.

Manufacturer Narrative

Analysis: a review of the complaint was conducted.Upon removing the device from the bio-hazard bag it was noticed that the balloon had become separated from the catheter shaft 7cm from the proximal balloon cone.The balloon did not appear to have been damaged.The details indicate that the balloon was cut to remove the catheter from the sheath.The investigator was able to confirm a pinhole puncture in the middle of the proximal balloon cone.The catheter shaft appears to have been stretched and necked down over a 10cm length.The catheter usable length as supplied is 80cm.The usable length when measured was 96cm.This indicates that a large amount of force was applied to the catheter prior to deciding to cut the balloon.A review of the shaft tensile test data for this lot of catheters indicates that the minimum break strength of 20 samples tested was 24.9 newtons.The minimum tensile requirement is 15 newtons.The details indicate that the physician may not have allowed adequate time for the balloon to fully deflate prior to attempting to withdraw the catheter back through the introducer sheath.If this was the case it would explain how the shaft was stretched and damaged.The instructions for use specify not force passage or withdrawal of the guide wire or delivery system if resistance is encountered.A full review of the catheter lot history records was performed.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 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).Stent retention testing.Stent must have retention = 5.5 newtons (n) for 7fr introducer sheath/guide.Proximal balloon bond tensile strength must meet or exceed 15n of force.The minimum tensile strength achieved during the lot qualification testing of 20 samples was 24.9n.Well above the 15n requirement.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Summary: based on the review of the complaint details, the physical device and the device history records review, atrium medical cannot conclude that the device was defective.It is possible that the balloon was not allowed adequate time to deflate prior to attempting to withdraw the catheter.When fluid is left in the balloon it acts like a plug prohibiting the balloon from coming back through the introducer sheath.The instructions for specify 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 step 7.Step 7.While maintaining guidewire position and negative pressure on the inflation device slowly withdraw the delivery catheter.¿.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, ILLIAC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7652675
• MDR Text Key: 112805987
• Report Number: 3011175548-2018-00679
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 06/29/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/17/2020
• Device Model Number: 85361
• Device Catalogue Number: 85361
• Device Lot Number: 248848
• Initial Date Manufacturer Received: 06/22/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 07/18/2018
• Supplement Dates FDA Received: 07/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention