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

Model Number 85364

Device Problems Detachment Of Device Component (1104); Inflation Problem (1310); Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient had a left common iliac stenosis which required realigning via a v12 covered stent.Access was straight forward.Upon deployment the v12 partially deployed but the balloon then failed to continue inflating.The delivery system was removed to discover the balloon had detached from the main delivery device.A snare was used in order to retrieve the balloon and a second pta balloon was used to fully deploy the stent.

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 in the center of the proximal balloon bond.It appears as if the shaft had necked down to a smaller diameter at this location prior to the shaft breaking.The balloon was also evaluated.There appears to be a small hole in the center of the balloon but is difficult to locate as getting fluid into the balloon has proven to be difficult.The distal end of the balloon is round and bulbous as when the balloon was being removed the fluid was pushed into the distal balloon cone.This creates a bulbous plug at the distal end of the introducer sheath making removal difficult.Multiple questions were sent to the institution on several occasions to help aid in the investigation.No answers were provided.One question of particular interest was if the lesion contained any large calcifications that make have caused the balloon to rupture.The instruction for use in the contraindications states the following in regards to calcifications: ¿heavily calcified lesions resistant to pta¿.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 (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 = 5.5 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 23n.Well above the 15n requirement.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, the physical device and the device history records review, atrium medical cannot conclude that the device was defective.It is possible that the balloon ruptured on a highly calcified lesion but this has not been confirmed by the institution or the physician.

Event Description

N/a.

• 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: 7652679
• MDR Text Key: 112805997
• Report Number: 3011175548-2018-00678
• 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: 07/25/2018

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: 04/11/2020
• Device Model Number: 85364
• Device Catalogue Number: 85364
• Device Lot Number: 249643
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/19/2018
• Initial Date FDA Received: 06/29/2018
• Supplement Dates Manufacturer Received: 06/19/2018
• 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