MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION CCF BALLOON EXPANDABLE COVERED STENT

Model Number 86004

Device Problem Detachment Of Device Component (1104)

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

Event Type  Injury  

Event Description

The stent came off the balloon prior to deployment.

Manufacturer Narrative

The reported device is for "investigational use only" reference (b)(4).The event is being reported because the device is similar to atrium's icast devices.A device history record review was performed and the device was found to have met all specifications.The actual device was not returned, therefore an evaluation could not be performed.The physician stated that the stent was being put through more stress than should be expected, and that the stent did not malfunction, was very pleased how the stent worked.No patient consequences reported.Attempts to obtain additional information have not been successful.If additional information becomes available a follow-up shall be submitted.

• Brand Name: CCF BALLOON EXPANDABLE COVERED STENT
• Type of Device: NA
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: lori gosselin, sr. specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3809680
• MDR Text Key: 4522138
• Report Number: 1219977-2014-00019
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/23/2014

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: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 86004
• Device Catalogue Number: 860004
• Device Lot Number: P0130322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 02/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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): Other
• Patient Weight: 99