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

Model Number 85392

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 02/28/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician had difficulty removing the balloon after deployment.The balloon ruptured and was recovered with the removal of the introducer.

Manufacturer Narrative

Analysis: as the device in question and the introducer sheath used in the case were not returned an evaluation of the physical product cannot be performed.Based on the information provided it appears that the balloon was separated from the catheter shaft while attempting to pull the balloon back through the introducer sheath due to a possible rupture of the balloon.As the device appears to have been used in conjunction with an aortic endograft there is a possibility that the balloon was ruptured on one of the fixation barbs of the endograft.If there is a hole in the balloon full deflation of the balloon may not have been obtained.Per the product user requirements the proximal balloon bond must not break at a force below 15 newtons (n).A review of the proximal balloon bond tensile force data collected during the quality performance testing that every lot of catheters manufactured is subjected to be reviewed to ensure the minimum specification for proximal bond tensile force was met.The review shows that the units were proximal balloon bond tensile tested from this catheter lot and the minimum tensile break force recorded was 27.2 n.The minimum allowable break tensile force as specified in the advanta v12 otw vascular covered stent product requirements is 15 n.The minimum break force seen from this production lot exceeds this requirement by 12 n.A review of the proximal and distal skive dimensions found within the device history records lot number 455126 shows that all product dimensional requirements were met for skive dimensions per part specification.If one or both of the skive holes were not patent during stent deployment, either the stent would have not deployed or the stent would have been pushed off the balloon partially deployed as fluid would only inflate one half of the balloon.Being that the stent was deployed without issue it is reasonable to conclude that the inflation lumens and skive holes were all patent prior to and after stent deployment.If the balloon of the advanta v12 had ruptured at some point during the procedure this could potentially prohibit the balloon from deflating fully prior to catheter withdrawal.A review of the balloon test data located in device history record shows that all balloons tested were able to withstand the 5 inflate/deflate cycles at the rated burst pressure of 12 atm as indicated on the product label.None of the test samples at lot qualification testing ruptured.The same samples are then balloon burst tested to ensure the balloon ruptures above the 12 atm label specification for rated burst pressure.The lowest balloon pressure recorded was 19.9 atm out of the samples tested.A review of the balloon burst data from the balloon forming device history records shows that the lowest balloon burst pressure of samples tested was 19.7 atm.In all accounts the balloon exceeded well over the 12 atm requirement.Below is an overview of the quality and performance criteria that every lot of advanta 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).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.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.Atrium medical only releases production lots that have passed the aforementioned performance and quality requirements.Conclusion: the separation of the balloon from the catheter shaft cause is unknown based on the review of the product details provided by the institution and review of the device history records.There is no evidence to conclude that the product was not conforming to the quality and performance requirements that every advanta v12 covered stent delivery system is manufactured to.There is a possibility that the balloon was not deflated fully prior to attempting to pull the deflated balloon back thorough the introducer sheath but this cannot be confirmed without fluoroscopic images of the deflated balloon prior to withdrawal.There is also a possibility that the balloon was ruptured on a fixation barb of the endograft used in the case but cannot be confirmed.

• 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: 9824434
• MDR Text Key: 183144967
• Report Number: 3011175548-2020-00405
• 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: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2023
• Device Model Number: 85392
• Device Catalogue Number: 85392
• Device Lot Number: 455403
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention