MAUDE Adverse Event Report: MICROVENTION, INC. LVIS JR 2.5 X 17; EMBOLIZATION COIL

Model Number 172014-CASJ-C

Device Problems Sticking (1597); Unintended Movement (3026)

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

Event Date 04/01/2015

Event Type  Injury  

Event Description

Stenting treatment was conducted of an aneurysm.It was reported that while retracting the delivery pusher, the stent tyne became stuck on the catheter tip.As the device was pulled, the stent was moved to an unintended location.The stent was left in position and an additional stent was positioned and deployed at the intended legion site successfully.No injury was reported with the pt as a result of the procedure.

Manufacturer Narrative

The delivery pusher was returned and confirmed the implant was detached.No anomalies were identified with the delivery pusher.The microcatheter was not available for eval, nor the stent as remains within the pt.(b)(4).

• Brand Name: LVIS JR 2.5 X 17
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; tustin CA
• Manufacturer Contact: teri halverson ; 1311 valencia; tustin, CA 92780 ; 7142478000
• MDR Report Key: 4797806
• MDR Text Key: 5820605
• Report Number: 2032493-2015-00077
• Device Sequence Number: 1
• Product Code: NJE
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 02/28/2018
• Device Model Number: 172014-CASJ-C
• Device Lot Number: 150206LC2
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2015
• 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): Disability
• Patient Age: 51 YR
• Patient Weight: 70