MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION I-CAST COVERED STENT ; I-CAST STENT

Model Number REF# 85415

Device Problem Material Separation (1562)

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

Event Date 04/15/2016

Event Type  Injury  

Event Description

I-cast stent inserted by md.Before stent in position, md noted the stent had moved off the balloon.System removed with stent intact.Ref mfr.#: 1219977-2016-00076.

• Brand Name: I-CAST COVERED STENT
• Type of Device: I-CAST STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• MDR Report Key: 5651105
• MDR Text Key: 45096336
• Report Number: 5651105
• Device Sequence Number: 1
• Product Code: JCT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/18/2016,04/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2018
• Device Model Number: REF# 85415
• Device Lot Number: 231376060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/15/2016
• Device Age: NA
• Event Location: Hospital
• Date Report to Manufacturer: 04/19/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/12/2016
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 70