MAUDE Adverse Event Report: ATRIUM MEDICAL ADVANTA V12; STENT, ILLIAC

Model Number 85361

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2018

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon the receipt of the event sample and the completed investigation.

Event Description

When using the advanta v12 the stent came off the balloon as it advanced.The catheter and stent could be removed.There is no patient injury.

Manufacturer Narrative

A review of the complaint details was conducted.The provided information indicates that the stent was dislodged as it passed through the introducer sheath.As the device in question was not returned an evaluation of the product cannot be conducted.If it had been returned the stent and balloon of the catheter would have been evaluated to ensure that the stent was crimped properly during the manufacture of the product.The sheath would have also been evaluated to ensure there were no signs of damage that could have prevented the stent from passing through the sheath.A full review of the catheter lot history records was performed.Below is an overview of the quality and performance criteria that every lot of 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 (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).Stent retention testing.Stent must have retention = 5.5 newtons for 7fr introducer sheath/guide.This lot of catheters passed all quality and performance criteria without any non-conformances related to the complaint.The minimum stent retention value observed during the testing was 11.3 newtons.Based on the review of the complaint details and the device history records review atrium medical cannot conclude that the stent dislodgement was a fault of the design or manufacture of the device.

Manufacturer Narrative

A review of the complaint was conducted.The stent was evaluated to determine if it had migrated off the balloon.The stent was firmly crimped in position between the two radiopaque ro marker bands.The stent was not loose as stated in the complaint details.The diameter of the stent was measured and was of the same diameter of the other stents measured prior to lot qualification performance testing.The catheter shaft was slightly damaged approximately 40cm from the inflation manifold.In an attempt to determine the functionality of the returned device a.035¿in cordis emerald green guidewire was inserted through the guidewire lumen of the catheter.The catheter was then passed through a 7fr cook introducer sheath.The device was then prepped per the instructions for use and the stent deployed.The product performed perfectly.The stent deployed evenly between the two ro marker bands.The balloon was then deflated and the delivery system was pulled back through the sheath without issue.Based on the review of the complaint details, the physical device and the device history records review, atrium medical cannot conclude that the device was defective as it performed properly when evaluated.

Event Description

N/a.

• Brand Name: ADVANTA V12
• Type of Device: STENT, ILLIAC
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer (Section G): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• Manufacturer Contact: 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 7499901
• MDR Text Key: 107772676
• Report Number: 3011175548-2018-00469
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2020
• Device Model Number: 85361
• Device Catalogue Number: 85361
• Device Lot Number: 418429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Is the Reporter a Health Professional?: Yes
• Device Age: YR
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AMPLATZ 180CM WIRE7F 55CM COOK ANSEL 1 LOCK
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 80