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

Device Problem Break (1069)

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.Associated file: mdr 1219977-2015-00301.

Event Description

It was reported that a stent came off the balloon during a fenestrated endovascular case.It came off the balloon as it was being placed into the sheath.

Manufacturer Narrative

Engineering analysis: the details indicate that the stent was removed from the balloon as it was being placed into the sheath.No sample has been returned therefore an evaluation of the dimensions of the crimped stent could not be performed.The crimped stent leaves impressions of the stent frame on the surface of the balloon that indicate if the balloon was properly crimped.The stent delivery system was not returned so this evaluation could not be performed.The introducer sheath used in the case was also not returned.Engineering summary: as the lot number of the icast device in question was not provided a review of the catheter lot history records for the device in question could not be performed.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.Conclusion: based on the details of the event 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: 5150492
• MDR Text Key: 28303502
• Report Number: 1219977-2015-00302
• 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: Health Professional
• Type of Report: Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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