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

Model Number 85364

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during the procedure, while the endograft was being stented with a balloon expandable stent, the balloon came off of the end of the apparatus.The balloon was able to be retrieved.No patient harm reported.

Manufacturer Narrative

Analysis: the details of the complaint provided by the institution state that: ¿it was reported that during an endovascular procedure the iliac artery was stented.The physician felt resistance on removal and the balloon came off the end of the catheter.It was retrieved at this time.No patient harm.¿ 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.Per the product user requirements the proximal balloon bond must not break at a force below 15 newtons (n).For the proximal balloon bond to break during withdrawal a force greater than 15n must have been applied while attempting to pull the balloon back through the introducer sheath.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 units were proximal balloon bond tensile tested from this catheter lot and the minimum tensile break force recorded was 22n.The minimum allowable break tensile force as specified in the advanta v12 otw vascular covered stent product requirements is 15n.The minimum break force seen from this production lot exceeds this requirement by 7n.A review of the proximal and distal skive dimensions found within the device history records shows that all product dimensional requirements were met for skive dimensions.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 shows that all balloons tested were able to withstand the 5 inflate/deflate cycles at the rated burst pressure of 12atm 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 12atm label specification for rated burst pressure.The lowest balloon pressure recorded was 20.1atm 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 tested was 19.4atm.In all accounts the balloon exceeded well over the 12atm requirement.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 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 it back thorough the introducer sheath but this cannot be confirmed without fluoroscopic images of the deflated balloon prior to withdrawal.The instructions for use specify the following in regards to balloon deflation: 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.Note: it is recommended that the guidewire remain across the lesion until the procedure is completed.H3 other text : not available for return.

• 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: 9796142
• MDR Text Key: 186840942
• Report Number: 3011175548-2020-00365
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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: 09/05/2021
• Device Model Number: 85364
• Device Catalogue Number: 85364
• Device Lot Number: 450599
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/05/2020
• Supplement Dates Manufacturer Received: 04/10/2020
• Supplement Dates FDA Received: 04/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1