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

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 06/19/2014

Event Type  Injury  

Event Description

Report stated that a patient with stenosis had a self-expanding stent previously placed.After placing the v12 stent and deflating the balloon, the balloon snapped off the catheter while retrieving the catheter through the sheath.The balloon stayed in the vessel and the surgeon pushed it to the sidewall with 2 bare-metal stents.

Manufacturer Narrative

We are awaiting the return of the device for investigation and additional information regarding the complaint.The final report shall be submitted once the evaluation is completed.

• Brand Name: V12 COVERED STENT
• Type of Device: COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORP.; hudson NH
• Manufacturer Contact: lori gosselin, sr. qa spec ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3940334
• MDR Text Key: 4577239
• Report Number: 1219977-2014-00195
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 06/20/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/20/2014
• Initial Date FDA Received: 06/26/2014
• 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