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

Model Number 85343 - ADVANTA V12 COVERED STENT 6MMX22MMX80CM

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The 6 x 22 x 80 was used in the left renal for a fenestrated evar case with a 6fr anl cook sheath.The balloon was inflated with 1/3, 2/3 contrast and saline.Once the balloon was deflated the clinician struggled to get the balloon back in to the sheath.The stent was deployed successfully and there was no harm to the patient.

Manufacturer Narrative

Analysis: the returned v12 covered stent delivery system was evaluated to determine the cause of the complaint.The introducer sheath used in the case was not returned.Upon removal from the packaging the delivery system was covered in dried bodily fluids and the balloon had a slight curve to it.The curvature is due to the device tracking in and out of the renal artery.The turn into the renal artery can be at a 90 degree angle.The balloon was in the folded position and did not appear to have any stress applied as the balloon is not bunched up from attempts to pull it through the introducer sheath.The shaft also did not show signs that it had been stretched.In an attempt to determine if the device was still functional a 20cc insufflator was connected to the catheter and prepped per the instructions for use.When inflated to the nominal inflation pressure of 8atm as specified on the product label, the balloon was pressurized and showed no signs of leaks.The pressure was then increased to 12atm.This is the balloons rated burst pressure as specified on the product label.The device performed properly.The device was then deflated without issue it is not known how long the balloon was allowed to deflate during the case prior to attempting to remove the deflated balloon, however if not enough time is allowed the remaining contrast in the balloon gets pushed to the distal tip of the balloon creating a bolus of fluid and acts like a plug at the end of the introducer sheath.A review of the device history records indicates that this lot of v12 covered stents passed all performance and quality requirements.Below is a list 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) 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 as detailed above.Distal tip tensile testing.Catheter leak check.Conclusion: based on the investigation there is a possibility that the balloon was not allowed to deflate fully prior to attempting to withdraw the catheter back through the introducer sheath.As the device was fully functional atrium medical cannot conclude that the device in question was at fault.

• Brand Name: STENTS ADVANTA V12
• Type of Device: STENT, RENAL
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack NH 03054
• MDR Report Key: 8828327
• MDR Text Key: 153221835
• Report Number: 3011175548-2019-00806
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2022
• Device Model Number: 85343 - ADVANTA V12 COVERED STENT 6MMX22MMX80CM
• Device Catalogue Number: 85343
• Device Lot Number: 446054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ZENITH FENESTRATED ENDOVASCULAR GRAFT - COOK
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR