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

Model Number 85415

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2016

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 came off of the balloon upon attempting implant.No harm to the patient.

Manufacturer Narrative

Engineering analysis: the icast was removed from the packaging and inspected to determine the cause of the complaint.The catheter was clean and had no signs of contamination from blood anywhere on the stent or the delivery system.There was a noticeable kink in the catheter shaft just prior to the proximal balloon weld.The stent was properly positioned between the radio opaque marker bands (ro markers) and was not loose on the balloon.The crimped stent diameter was measure and was 2.4mm.This diameter is indicative of a properly crimped stent and matches the quality inspection data attached to this investigation.To determine the functionality of the returned device the delivery system was prepped and the stent deployed to 8atm and then 12atm.Nominal deployment pressure as specified on the product label is 8atm and the rated burst pressure is 12atm.The stent deployed properly and was situated between the two ro marker bands as expected.The device is fully functional.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 atrium's 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 non-conformances noted during the final lot qualification testing related to the stent.None of the samples tested had any stent movement while passing the device 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.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 and a hemostatic valve that is too tight.The instructions for use state that, "special care must be taken not to handle or in any way disrupt the placement of the icast stent on the balloon." 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 the potential harm of a delay in treatment 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: 5688898
• MDR Text Key: 46212542
• Report Number: 1219977-2016-00098
• Device Sequence Number: 1
• Product Code: JCT
• UDI-Device Identifier: 00650862854152
• UDI-Public: 00650862854152
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2016

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: 09/30/2018
• Device Model Number: 85415
• Device Catalogue Number: 85415
• Device Lot Number: 229375
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2016
• Initial Date FDA Received: 05/31/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2015
• 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
• Patient Age: 81 YR