MAUDE Adverse Event Report: ATRIUM MEDICAL CORP. V12 COVERED STENT

Model Number 85353

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2004

Event Type  Injury  

Event Description

Received a report stating that while introducing the stent into the patient the surgeon noticed that the device was detached from the balloon.No harm to patient.

Manufacturer Narrative

We are awaiting the return of the device for investigation and will submit the follow-up report once the evaluation is completed.

• Brand Name: V12 COVERED STENT
• Type of Device: COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH 03051
• Manufacturer Contact: lori gosselin, sr. qa speciali ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 4185790
• MDR Text Key: 21970074
• Report Number: 1219977-2014-00346
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/13/2014

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: 05/31/2017
• Device Model Number: 85353
• Device Catalogue Number: 85353
• Device Lot Number: 208367
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/13/2014
• Initial Date FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2014
• 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