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

Model Number 85360

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/04/2020

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 placement of the stent, the balloon separated from the catheter.The balloon was recovered and removed.No consequence for the patient.

Manufacturer Narrative

Additional information: a1, a2, a3 and a4.Analysis: the details of the complaint provided by the institution indicate that the balloon of the advanta v12 detached upon withdrawing the deflated balloon back through the introducer sheath.The images provided do not show that the balloon had been separated from the catheter shaft at the location of the proximal balloon to catheter shaft bond.The images show that the catheter shaft had necked down to a smaller diameter prior to breaking.The balloon appeared to be very much larger in the distal section of the balloon.This larger appearance of the distal end of the balloon is likely due to fluid still being in the balloon while attempting to pull the balloon back through the introducer sheath.The details provided and subsequent questions indicate that the balloon was only allowed 15 seconds to deflate.The instructions for use specify the following in regards to balloon deflation time: ¿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¿.If the balloon is not allowed sufficient time to fully deflate, upon withdrawal the remaining fluid in the balloon gets pushed to the distal end of the balloon creating a bolus of fluid that can act like a plug at the distal end of the introducer sheath.Based on the physical review of the product there is nothing that would have prevented the balloon from deflating fully if allowed to deflate for the required 40 seconds as indicated in the product instructions for use.As the lot number of the device in question was provided a review of the device history records was conducted.Each lot of advanta v12 covered stents is 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.A review of the relevant data within the device history records was also reviewed.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.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 was reviewed to ensure the minimum specification for proximal bond tensile force was met.The review shows that the minimum tensile break force recorded was 22.3 n.The minimum allowable break tensile force as specified in the advanta v12 otw vascular covered stent product is 15 n.The minimum break force seen from this production lot exceeds this requirement by over 7 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 per part specification.Conclusion: 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.The cause of the complaint is likely that the balloon was not deflated fully prior to attempting to pull the deflated balloon back thorough the introducer sheath as the details indicate only 15 seconds was allowed for the balloon to deflate.H3 other text : not retuned.

Event Description

N/a.

• 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: 10099631
• MDR Text Key: 193291676
• Report Number: 3011175548-2020-00732
• 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: 05/28/2020

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: 07/13/2022
• Device Model Number: 85360
• Device Catalogue Number: 85360
• Device Lot Number: 448801
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/25/2020
• Initial Date FDA Received: 05/28/2020
• Supplement Dates Manufacturer Received: 06/08/2020
• Supplement Dates FDA Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Weight: 81