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

Model Number 85324

Device Problem Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/05/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

When preparing to place a stent during an abdominal aortic aneurysm repair, the device was noted to be bent when it came out of the box.No clinical consequences for the patient.

Manufacturer Narrative

Analysis: the device was returned and evaluated to determine the cause of the complaint.Upon viewing the returned catheter it was evident that the catheter shaft had become kinked just prior to the proximal balloon bond.There was no other damage noted during the inspection.The details provided indicate that this damage was noticed straight out of the package.To ensure the performance of the v12 covered stent system a guide wire was placed through the catheter shaft and the device prepped per the instructions for use (ifu).The device was then inflated and the stent deployed at the nominal pressure rating of 8atm as specified on the product label.The pressure was then increased to the rated burst pressure of 12atm as specified on the product label.The stent deployed properly and when the balloon was evacuated by pulling a vacuum using the syringe, the balloon deflated properly.The device even though kinked, still performed properly.It is unknown how or where the damage occurred, however manufacturing during the packaging process inspects the device for damage such as this at two different locations within the packaging procedure mp001713 packaging catheters, tray.The details of the inspection are below and are excerpts from the actual procedure used.1.Inspect the catheter shaft for kinks by running fingers along the length of the shaft.Turn the sample 90 degrees and repeat the tactile inspection.Reject any extrusion that has a kink and record it on the applicable tracking form.2.Loop the catheter around the molded ring of the tray, being careful not to kink the catheter shaft.When properly loaded, the manifold fits into the upper left corner cavity for both catheter lengths.Reject and record any catheter which kinks during packaging.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 (6fr/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 10 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.Atrium medical only release production lots that have passed the aforementioned performance and quality requirements.Conclusion: based on the details provided there is not enough evidence to conclude that the v12 device was damaged prior to packaging or during the packaging process.The above manufacturing steps show that the catheter has a 200% inspection during the packaging process to ensure no damaged product is placed in the package.It is possible that the catheter shaft was damaged while the device was being removed from the packaging tray however his cannot be confirmed.

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 7919942
• MDR Text Key: 122305131
• Report Number: 3011175548-2018-01056
• Device Sequence Number: 1
• Product Code: NIN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/29/2021
• Device Model Number: 85324
• Device Catalogue Number: 85324
• Device Lot Number: 427099
• Date Manufacturer Received: 10/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention