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

Model Number 85365

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/16/2020

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reported that the balloon separated from the catheter on removal.The balloon was partially deflated so it could not be withdrawn back into the sheath.

Event Description

N/a.

Manufacturer Narrative

The advanta v12 was not returned for evaluation and no images of the device were provided.Multiple good faith efforts were made to obtain more detailed information and to request if the device was available for return without any success.The details provided indicate that "during the procedure, the carrier balloon tore off after the stent was released upon retraction and remained in the sheath.After that it could only be removed with this sheath.The balloon remained partially insufflated, so that its diameter was larger than that of the sheath the balloon was separated from the catheter shaft upon withdrawal back through the introducer sheath".Based on the details they suggest that the balloon had not been allowed sufficient time to deflate prior to withdrawing the balloon back into the introducer sheath.This is why the balloon was claimed to be "partially insufflated".If the balloon was not allowed the recommended time to deflate as indicated in the instructions for use, upon withdrawal of the balloon back into the introducer sheath the remaining fluid in the balloon gets pushed into the distal end of the balloon creating a bolus of fluid that could prevent the balloon from completely entering the sheath.The instructions for use specify the following in the deployment section line #6."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 to step 7".The details also mention that the balloon was separated from the catheter shaft.The proximal balloon weld tensile data of the 20 samples were tested for the minimum tensile test force requirement of 15 newtons as documented in the product requirements specification.Based on the device history record review the minimum proximal balloon weld tensile strength of the 20 tested samples was 24.6 newtons which is well above the minimum specification requirement.Further review of the instructions for use states in the warnings and caution section line item #10."do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered".For the shaft to break separating the balloon from the catheter shaft it is reasonable to conclude too much force was applied.As the details provided indicate, the advanta v12 covered stent was deployed indicating that the inflation lumens of the catheter were patent.A review of the balloon inflation skive dimensions as recorded in the device history record show that all dimensions were within specification.Based on the complaint details and device history record review the investigation cannot conclude that the balloon separation from the shaft was due to the design or manufacture of the product and it cannot be confirmed that the device was the cause of the reported 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: 10211948
• MDR Text Key: 197301297
• Report Number: 3011175548-2020-00874
• 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: 06/30/2020

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: 07/08/2021
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 448460
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/29/2020
• Initial Date FDA Received: 06/30/2020
• Supplement Dates Manufacturer Received: 10/18/2020
• Supplement Dates FDA Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR