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

Model Number 85364

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that after successful deployment of the stent the physician was unable to retrieve the deflated balloon.The introducer and balloon catheter had to be withdrawn together.

Manufacturer Narrative

Analysis: the returned device was evaluated to determine the cause of the complaint.Upon opening the returned device the balloon was 95% inside the distal end of the 7fr introducer sheath.The distal balloon cone of the pet balloon was still partially outside the introducer sheath.Under magnification the distal tip of the introducer was inspected for damage.The edges of the soft tip of the introducer sheath were flared and deformed.See image below.It is not known if the advanta v12 was the only device to pass through the provided 7fr introducer sheath.The distal balloon cone was slightly bulbous as if fluid may have collected at the distal tip of the balloon.The catheter shaft was inspected for damage as well.Significant elongation of the catheter shaft was noted approximately 30cm from the inflation manifold.To determine the functionality of the device a 130cm guidewire was advanced the length of the delivery system entering at the distal tip of the catheter and exiting through the inflation manifold.The catheter delivery system was advanced pushing the balloon back out of the introducer sheath.The balloon of the catheter was then inflated to nominal pressure (8atm) as specified on the product label.The balloon was then deflated allowing 40 seconds to deflate per the instructions for use.The balloon was then slowly withdrawn back through the introducer sheath without issue.Some resistance was encountered but nothing out of the normal resistance.A full review of the catheter lot history records for the devices in question was performed.The records indicate that this lot of catheters passed atriums final lot qualification testing.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.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).Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing associated with the complaint.There were no issues in regards to the stents being able to pass through the introducer sheath or the deflated balloons ability to come back through the introducer sheath after deployment of the stent.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.Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: the root cause of the complaint could not be determined as none of the specific questions that were asked of the institution were answered.Based on the results of the investigation it appears as if the balloon was not allowed adequate time to fully deflate using a 20cc syringe prior to withdrawing the balloon back through the introducer sheath.Clinical evaluation: the instructions for use (ifu) state 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 ifu also warns "do not force passage or withdrawal of the guidewire or delivery system if resistance is encountered" and instructs to "deflate the balloon by pulling vacuum on the inflation device to its maximum volume for 40 seconds.Verify full balloon deflation via fluoroscopy before proceeding.While maintaining guidewire position and negative pressure on the inflation device slowly withdraw the delivery catheter.".

• Brand Name: ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 40 continental blvd; merrimack 03054
• Manufacturer Contact: lynda mclaughlin,rn,bsn,ccrn-k ; 40 continental blvd; merrimack, NH 03054
• MDR Report Key: 6971162
• MDR Text Key: 90041307
• Report Number: 3011175548-2017-00163
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/09/2020
• Device Model Number: 85364
• Device Catalogue Number: 85364
• Device Lot Number: 248183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• 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
• Patient Outcome(s): Required Intervention