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

Model Number 85453

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/21/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician chose to use a stent to seal a carotid perforation due to a stab wound.He passed the stent through an 8fr sheath in an effort to deliver the stent to the carotid.Upon exiting the catheter the physician noticed that the stent was loose on the balloon.To maintain control of the situation he then parked the stent in an unaffected area of the carotid.

Manufacturer Narrative

Engineering analysis: the investigation into the reason for the complaint is difficult due to the fact that the device was not returned.The introducer also was not returned.The details provided indicate that the introducer sheath used was an 8fr introducer sheath.This product is compatible with a 6fr introducer sheath as indicated on the product label.As an 8fr introducer sheath was used there would have been ample room for the crimped stent delivery system to pass through the sheath.It is very possible that the anatomy tortuosity caused the introducer sheath to deform or kink making passage difficult that may have ultimately caused the stent to dislodge.The details provided indicate that the target vessel was the carotid artery.Without images from the procedure it is difficult to determine the tortuosity of the patient's anatomy and determine if the sheath may have kinked at some point taking a turn into the carotid artery.During the final lot qualification data shows that all 59 test samples were able to pass through the 6fr introducer sheath without issue.Since december of 2013 over 30,000 test units have been passed through the introducer sheath without a failure for the inability of the stent to pass through the introducer sheath.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sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during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.None of the samples tested had an issue passing through the labeled introducer sheath or the inability to pass through the introducer sheath.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) · manifold to shaft tensile testing.Samples when tensile tested must not break or separate below 3.37lbs result: all 59 quality inspection samples passed this final inspection without any performance related issue or the inability to pass through the introducer sheath.Conclusion: based on the details of the event and the successful lot qualification test data atrium can find no fault with the device and or lot of stent delivery systems in question.

• Brand Name: ATRIUM ICAST 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 ; 40 continental blvd.; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 5172135
• MDR Text Key: 29211998
• Report Number: 1219977-2015-00314
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K050814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 04/30/2018
• Device Model Number: 85453
• Device Catalogue Number: 85453
• Device Lot Number: 222885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2015
• 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