MAUDE Adverse Event Report: ATRIUM MEDICAL CORPORATION V12; COVERED STENT

Model Number 85350

Device Problem Detachment Of Device Component (1104)

Patient Problem No Information (3190)

Event Date 03/27/2014

Event Type  Injury  

Event Description

Stent was correctly prepped by nursing scrub staff.Md inserted a 6fr flexor sheath into the left femoral artery with no problems and used a rosen wire to access the vessel.On his first attempt to put the 5x16x120 stent into the valve; he could see the stent "coming off" the balloon.He then pulled back the balloon/stent but was never able to get the stent fully into the valve of the sheath.He then removed it completely and attempted to re-crimp the stent onto the same atrium balloon & was unsuccessful.Md used the next size up - a 6x16x80 through the same 6fr sheath and the product performed perfectly and md was happy with the outcome.

Manufacturer Narrative

We are awaiting the return of the device for investigation.A follow-up report shall be submitted upon completion of the evaluation.

• Brand Name: V12
• Type of Device: COVERED STENT
• Manufacturer (Section D): ATRIUM MEDICAL CORPORATION; hudson NH
• Manufacturer Contact: lori gosselin, sr. specialist ; 5 wentworth dr.; hudson, NH 03051 ; 6038801433
• MDR Report Key: 3796704
• MDR Text Key: 4365339
• Report Number: 1219977-2014-00134
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/28/2014

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: 12/31/2014
• Device Model Number: 85350
• Device Catalogue Number: 85350
• Device Lot Number: 10817124
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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
• Treatment: FLEXOR SHEATH - 6FR: ROSEN GUIDEWIRE
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 85