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

Model Number 85455

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the stent came off the balloom once it was inside the hemostatic valve.

Manufacturer Narrative

Engineering analysis: on opening the returned device packaging it was noticed that the stent was not present with the returned stent delivery system.The introducer sheath used in the case was also not returned.The balloon was still in it folded position and there were no signs of damage upon the balloon or catheter shaft.The returned device balloon surface was evaluated to determine if the stent was crimped properly during manufacturing, (when the stent is crimped on to the folded balloon the stent frame leaves impressions of the stent frame on the surface of the balloon).The impressions indicate if the stent was properly crimped on to the balloon.The crimped stent impressions were clearly visible indicating that the stent was properly crimped during manufacturing.The product in question has 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sheath.The stent is then deployed at nominal pressure as specified on the product label and the balloon deflated and withdrawn back through the introducer sheath.This testing was conducted numerous times while being submerged in a heated water bath at 37°c (body temperature) during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 can cause stent dislodgement including but not limited to manipulation of the stent prior to use, overuse of the sheath causing failure of the hemostatic valve or a hemostatic valve that is too tight.Insufficient stent securement during access through the sheath may lead to the need for removal of the stent delivery system.This event may be associated with a delay in the procedure as well as the need for additional medical or surgical intervention.

• 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 rn, ccrn-k ; 40 continental blvd; merrimack, NH 03054 ; 6038645470
• MDR Report Key: 6088746
• MDR Text Key: 59456552
• Report Number: 1219977-2016-00229
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854558
• UDI-Public: 00650862854558
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 03/31/2018
• Device Model Number: 85455
• Device Catalogue Number: 85455
• Device Lot Number: 222731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/09/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/06/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• 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