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

Model Number 85361

Device Problem Retraction Problem (1536)

Patient Problem No Information (3190)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that a stent was successfully placed, however, the radiologist could not pull the delivery catheter back through the 'lock'.

Manufacturer Narrative

Engineering analysis: upon opening the returned device packaging the stent delivery system was present and the 7fr introducer sheath used in the case.The stent delivery catheter had been removed through the introducer sheath.Being that this case complaint was about the inability of the balloon to be withdrawn back through the introducer sheath this was not expected.The delivery system was inspected for damage and none was noted.The introducer sheath was also inspected for damage it was noticed that the sheath had been kinked in the middle of the sheath.There was also some deformity of the distal tip of the sheath.In an attempt to duplicate the complaint whereas the balloon would not come back through the introducer sheath, the balloon was placed through the returned introducer sheath accompanied by a.035 guidewire.The balloon was then inflated to a pressure of 12atm.This is the rated burst pressure of the balloon as specified on the product label.The balloon was then allowed to deflate and the balloon withdrawn back through the introducer sheath.There were no issues pulling the balloon back through the introducer sheath.This was repeated successfully three times.The final lot qualification data shows that all 20 test samples were able to pass through the 7fr introducer sheath without issue.The product in question has also been subjected to simulated use in a tortuous iliac artery model whereas the stent delivery system is advanced contra laterally over the iliac arch through a 7fr 55cm long cook check flow performer introducer sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during design verification testing of the product.Engineering summary: a full review of the catheter lot history records for the device 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 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).Result: all quality inspection samples passed this final inspection without any non-conformances noted during the final lot qualification testing.Conclusion: based on the details of the event and the successful lot qualification test data, atrium can find no fault with the lot of stent delivery systems in question.Clinical evaluation: there are several possibilities that could prevent the delivery catheter and balloon from reentering the sheath for withdrawal including angularity or tortuosity of the vasculature, the application of excessive manipulation or force, loss of wire opposition or damage to the sheath created by excessive use.If a balloon cannot be withdrawn back into a sheath it would cause a delay in the procedure and increase the patients risk by subjecting them to additional medical or surgical intervention.It is stated in the instructions for use, "do not force passage or withdrawal of the guide wire or delivery catheter if resistance is encountered.".

• Brand Name: ATRIUM ADVANTA V12 COVERED STENT
• Type of Device: PTFE COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer (Section G): ATRIUM MEDICAL CORPORATION; 5 wentworth drive; hudson NH 03051
• Manufacturer Contact: lynda mclaughlin rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6002416
• MDR Text Key: 56539776
• Report Number: 1219977-2016-00206
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 08/31/2018
• Device Model Number: 85361
• Device Catalogue Number: 85361
• Device Lot Number: 228291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2015
• 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