MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL SOFT; EMBOLIZATION COIL

Model Number	180208HC-S-V-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Device Issue (2379)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/14/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device involved in this event has not been returned for evaluation.Following completion of the investigation, a follow-up medwatch will be submitted.(b)(4).
Event or Problem Description
It was reported from (b)(6) that during the coil embolization treatment of a lmca (left main coronary artery), the last coil was positioned within the aneurysm sac.Upon deployment, the coil failed to detach.An attempt was made to remove the coil however, this was unsuccessful due to the coil mass.Multiple detachment attempts were made using the v-grip controllers.On the 11th attempt, the coil detached, however aneurysm perforation occured causing bleeding.Remedial action taken: pharmaceutical coma with full monitoring.No additional information has been provided.

• Brand Name: MICROPLEX HELICAL SOFT
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5787699
• Report Number: 2032493-2016-00161
• Device Sequence Number: 13620584
• Product Code: HCG
• UDI-Device Identifier: 00811425025895
• UDI-Public: (01)00811425025895(11)160228(17)210228(10)160228V7
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 02/28/2021
• Device Model Number: 180208HC-S-V-A
• Device Lot Number: 160228V7
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/15/2016
• Initial Report FDA Received Date: 07/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 45 YR
• Patient Weight: 65