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

Model Number 85327

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 03/16/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the balloon came off the carrier in the sheath on removal.

Manufacturer Narrative

Analysis: the details of the complaint provided by the institution indicate that the balloon became detached from the catheter shaft upon removing the catheter back through the introducer sheath.An image of the balloon protruding outside the 7fr introducer sheath suggests that the balloon was not fully deflated before attempting to withdraw the device back through the introducer sheath.This is evident as there is a bolus of fluid still within the distal balloon cone that is still outside the introducer sheath.The instructions for use 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¿.If the balloon is not allowed to fully deflate prior to withdrawal back through the sheath the remaining fluid in the balloon gets pushed to the distal balloon cone where it forms a bolus of fluid that acts like a plug making withdrawal difficult.If too much force is applied to the catheter the catheter shaft could break.The catheter shaft in the image also appears to have been stretched or necked down to a smaller diameter due to the force imparted when attempting to remove the catheter back through the introducer sheath.The warnings and cautions section of the instructions for use specify the following: ¿warnings and cautions: line 10; do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.¿ 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 15 n must have been applied while attempting to pull the balloon back through the introducer sheath.The introducer sheath used in the case was not returned.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 20 units were proximal balloon bond tensile tested from this catheter lot and the minimum tensile break force recorded was 24.5 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 over 9 n.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 (20) 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 20.2 atm out of 20 samples tested.A review of the balloon burst data from the balloon forming device history records shows that the lowest balloon burst pressure of 34 samples tested was 19.8atm.In all accounts the balloon exceeded well over the 12 atm requirement.Each lot of advanta v12 covered stents are required to pass the following quality and performance criteria: 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.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 and the image provided.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.However based on the image provided is the most likely cause of the complaint.

• 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: 9860356
• MDR Text Key: 186840985
• Report Number: 3011175548-2020-00436
• 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: 03/20/2020

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: 11/19/2022
• Device Model Number: 85327
• Device Catalogue Number: 85327
• Device Lot Number: 453546
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/18/2020
• Initial Date FDA Received: 03/20/2020
• Supplement Dates Manufacturer Received: 05/13/2020
• Supplement Dates FDA Received: 05/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 76