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

Model Number 85337

Device Problem Device Slipped (1584)

Patient Problem No Information (3190)

Event Date 09/03/2014

Event Type  Injury  

Event Description

The stent slipped off the balloon as it went through the introducer sheath.

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
• Manufacturer Contact: lori gosselin ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 4122253
• MDR Text Key: 15805018
• Report Number: 1219977-2014-00312
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 09/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2017
• Device Model Number: 85337
• Device Catalogue Number: 85337
• Device Lot Number: 212188
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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
• Patient Age: 72 YR