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 09/14/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the stent detached from balloon prior to implantation.

Manufacturer Narrative

Based on the details of the complaint the 8mm x 59mm stent dislodged off the balloon at some point after the stent delivery system was removed from the catheter tray.Multiple attempts were made to obtain additional information regarding the procedure in order to assist with the complaint investigation.Because none of the questions were answered, it is impossible to determine at what point prior to or during the procedure that the stent dislodged from its position on the balloon.A review of the device history records was performed and this production lot of catheters and sub assembly lots associated with the finished good lot number passed all product requirements including the stent retention (crimped stent securement) of the crimped stent to the balloon.The minimum stent retention value recorded was 8.95 newton¿s (n).The product requirement as detailed within the product requirements document states that the stent must not detach from the balloon at a value less than 5.5 n out of the box.In this regard, the production lot of catheters exceeded this requirement.It is also important to note that during the product lot performance testing that every lot of catheters is subjected to, a sampling of finished devices are passed through a introducer sheath to ensure the stent is secure on the balloon.The device history records show that all samples were passed through a 7fr introducer sheath without and movement of the stent or dislodgements.As the details provided do not indicate at what point the stent came off the balloon it is impossible to determine the cause of the stent dislodgement.Cause could be related to the size of the introducer sheath used in the case as the product label specifies the use of the 8mm x 59mm x 80cm catheter with a 7fr introducer sheath as specified on the product label.There is also a possibility that there was a lesion in whatever vessel that was being treated that was of a smaller diameter than that of the crimped stent.It is possible that too much force was applied in trying to cross the lesion.In this regard, the instructions for use states the following: step 7.Do not remove, reposition or hand crimp the stent.Step 8.Do not handle or in any way disrupt the placement of the stent on the balloon.Step 9.The delivery system is not designed for use with power injection systems.Step 10.Do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered.Based on the information provided, the lack of details after multiple good faith efforts to obtain more information and the results of the investigation the complaint cannot be confirmed.H3 other text: not available for return.

Event Description

N/a.

Manufacturer Narrative

Corrected information b3 and d4.

• 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: 10589711
• MDR Text Key: 209136361
• Report Number: 3011175548-2020-01166
• 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,Followup
• Report Date: 09/25/2020

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: 04/20/2023
• Device Model Number: 85327
• Device Catalogue Number: 85327
• Device Lot Number: 459135
• Initial Date Manufacturer Received: 09/21/2020
• Initial Date FDA Received: 09/25/2020
• Supplement Dates Manufacturer Received: 11/28/2020; 12/22/2020
• Supplement Dates FDA Received: 12/01/2020; 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 84 YR