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

Model Number 85365

Device Problem Defective Device (2588)

Patient Problem No Information (3190)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report received stated that during the process of placing the stent by passing through a cook 7 fr introducer, the treating doctor notes that the stent catheter is defective and cannot advance to the deployment site.

Manufacturer Narrative

Based on the details of the complaint the advanta v12 10mm x 59mm device was placed through the cook introducer sheath but the treating doctor noted that the stent or stent delivery system was damaged and could not advance to the deployment site.Based on the details provided it is unclear as to what damage was noted that prohibited the advanta v12 from reaching the target site.Multiple questions were asked of the complainant but none were answered in any detail that would lend itself into determining the root cause of the complaint or the problem observed during the procedure.The one response received was the following: "the procedure has been a endovascular aortic aneurysm repair with t branch device.Non lesions atherosclerosis and the goal of stent was connect t branch and renal artery.It has been impossible to advance the stent".Based on the details of the complaint it is difficult to determine at what point or where within the procedure the product was damaged or at what point in the procedure the device was unable to be advanced.Based on the details it is reasonable to assess that the advanta v12 as the details mention the device had been placed through the sheath.As this case was part of a t-branch aneurysm repair it is possible that the stent became stuck within the t-branch graft.Without the device in question or images from the case it is impossible to determine the root cause of the complaint.Some branch grafts also have fixation barbs that can puncture or damage the catheter if contact is made with the fixation barbs.During the process of manufacturing a sampling of devices is performance tested to ensure the integrity of the product from every production lot of catheters produced.The sampling is based on an aql sampling based on product lot size.Typically 13 to 20 samples are tested from every product lot.There has not been an incident during the product performance testing where a advanta v12 was unable to be placed through the introducer sheath going back 2 years.During the process of manufacturing at the final manufacturing inspection process (manufacturing final inspection, crimped stent delivery system, v12/icast ) every device is inspected to ensure the guidewire can be passed through the entire length of the device and the shaft inspected for any damage such as dents or kinks of the shaft as well as the tip of the catheter.Verification of the stent placement and overall cleanliness of the device.If a device is found to be damaged it is scrapped.Based on the details of the complaint, the lack of the physical product for evaluation or images from the procedure the complaint cannot be confirmed.H3 other text : device not available for return.

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: 10557850
• MDR Text Key: 208316026
• Report Number: 3011175548-2020-01148
• 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: 08/18/2021

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: 04/03/2023
• Device Model Number: 85365
• Device Catalogue Number: 85365
• Device Lot Number: 458430
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2020
• Initial Date FDA Received: 09/19/2020
• Supplement Dates Manufacturer Received: 07/30/2021
• Supplement Dates FDA Received: 08/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: COOK 7F INTRODUCER
• Patient Age: 59 YR