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

Model Number 85326 - ADVANTA V12 COVERED STENT DEL SYS 8X38X8

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 07/08/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on deployment of the stent the balloon burst.

Manufacturer Narrative

Analysis: upon opening the returned device it was clear that the balloon had separated from the main catheter shaft at the location of the proximal balloon bond.The balloon was partially folded; however, the distal end of the balloon closest to the tip did not appear to be folded down as much as the rest.The balloon was pressurized to determine if the balloon was punctured during the procedure.The balloon was able to maintain pressure indicating there was not a hole in the balloon.The details provided are difficult to follow; however, it appears as if the balloon became stuck at the end of the introducer sheath preventing the catheter from being withdrawn back through the introducer sheath.In some cases we have found that the balloon, after stent deployment, was not given sufficient time to deflate prior to attempting to pull the balloon back through the sheath.When this occurs the remaining fluid in the balloon gets pushed into the distal end of the balloon creating a bolus of fluid.This creates a plug at the end of the introducer sheath making withdrawal difficult.A review of the device history records indicates that this lot of advanta v12 covered stents passed all performance and quality requirements including proximal balloon bond tensile testing whereas the balloon is pulled off the catheter shaft to ensure the integrity of the proximal balloon weld.The results of the test indicate that the average tensile force at separation was 30 newton¿s (n).The minimum tensile force was 25 n.This is well above the 15 n requirements.Below is a list 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 (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 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).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 as detailed above.¿ distal tip tensile testing.¿ catheter leak check.Conclusion: based on the investigation and lack of procedural details atrium medical corporation cannot conclude that the device was defective.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8823637
• MDR Text Key: 152106171
• Report Number: 3011175548-2019-00804
• 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: 07/24/2019

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: 04/06/2022
• Device Model Number: 85326 - ADVANTA V12 COVERED STENT DEL SYS 8X38X8
• Device Catalogue Number: 85326
• Device Lot Number: 445261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Initial Date Manufacturer Received: 07/18/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 08/12/2019
• Supplement Dates FDA Received: 09/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention