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

Model Number 85355

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 01/14/2020

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 came off the balloon when it was inserted into the sheath.

Event Description

N/a.

Manufacturer Narrative

Analysis: the details of the complaint provided by the institution state that: ¿advanta v12 detached itself from the balloon during a procedure when it was inserted into the lock¿.A series of questions were sent to the institution for clarification.The details provided indicate that the intended target was the celiac trunk and when the stent was inserted through the oscor sheath, the stent could not be advanced far enough into the vessel.Therefore, this was pulled back into the lock.The stent detached at the end of the lock and about 2/3 got stuck in the lock and 1/3 in front of the lock.Based on this information it appears that the advanta v12 could not be advanced far enough into the vessel so the un-deployed stent was pulled back into the introducer sheath and the stent migrated off the balloon when coming back through the hub of the introducer sheath.Withdrawing an un-deployed stent back through the introducer sheath is clearly advised against in the instructions for use.The instructions for use specifically state the following: ¿warnings and cautions line 17.Do not pull an unexpanded stent back through a guiding catheter or sheath.Deployment caution: removal of an unexpanded or partially expanded stent extreme caution must be used when removal of an unexpanded or partially expanded stent is necessary.The stent/delivery system should be withdrawn until the proximal end of the stent is aligned with the distal tip of the sheath.The sheath and the stent/delivery system should then be removed as one unit.¿.The reason for the warning is that once the stent passes through the introducer sheath if you were to pull the stent back into the sheath there is a possibility that the proximal end of the un-deployed stent could catch the distal end of the introducer sheath.If this was to occur and enough force applied, the user could push the crimped stent off the balloon and leave the stent free floating in the vasculature.It is therefore suggested that the stent/delivery system be removed as one unit.A thorough review of the device history records was conducted to ensure the product met all quality and performance requirements including stent retention testing.Below is a list of the quality and performance criteria that every lot of advanta v12 covered stent systems is tested to.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 (6fr/7fr) depending on size.¿ 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 ¿ distal tip tensile testing.¿ catheter leak check.A review of the device history records indicates that this lot of catheters passed all quality and performance requirements.The device history record for stent crimping shows that the lowest stent retention data point recorded was 9.2 newtons (n).The minimum allowable stent retention force as specified in the advanta v12 otw vascular covered stent product requirements is = 5.5 n for 7fr introducer sheath/guide.This lot of advanta v12 covered stents passed this requirement.Conclusion: based on the review of the details supplied and review of the device history records it appears as if the stent migration off the balloon was caused by user error.The device was pulled back through the introducer sheath with the un-deployed stent still crimped on the catheter.Device not returned.

• 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: 9611031
• MDR Text Key: 186848834
• Report Number: 3011175548-2020-00085
• 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: 01/21/2020

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: 01/17/2022
• Device Model Number: 85355
• Device Catalogue Number: 85355
• Device Lot Number: 447926
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/14/2020
• Initial Date FDA Received: 01/21/2020
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LOCK OSCOR 7FR. SHEATH.
• Patient Outcome(s): Required Intervention