MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME FRAMING COIL 18-AV; EMBOLIZATION COIL

Model Number	181036HFRM-V-A
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device has not yet been returned to the manufacturer.The investigation is currently underway.
Event or Problem Description
It was reported that during placement of an embolization coil, the coil broke after approximately 2/3 of its length had been deployed.The coil was retrieved with a gooseneck snare device and the procedure was aborted.There was no reported patient injury.The patient's current status is reported to be "fine.".
Additional Manufacturer Narrative
The device was received for evaluation, without the pusher.The implant coil revealed a portion of the attachment monofilament, as it was separated from the delivery pusher.The implant was noted to be bent with a deformed secondary loop, which is likely due to being retrieved with the snare device.A firm conclusion could not be drawn from review of the fluoroscopic images provided.Based on the investigation and provided information, the complaint can be confirmed.The specific root cause of this complaint is not known.

• Brand Name: HYDROFRAME FRAMING COIL 18-AV
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6416041
• Report Number: 2032493-2017-00067
• Device Sequence Number: 1013232
• Product Code: HCG
• UDI-Device Identifier: 00811425027288
• UDI-Public: (01)00811425027288(11)160912(17)210831(10)160912V6
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K100454
• 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,Followup
• Report Date (Section B): 02/17/2017

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: 08/31/2021
• Device Model Number: 181036HFRM-V-A
• Device Lot Number: 160912V6
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/17/2017
• Supplement Date Received by Manufacturer: 02/17/2017
• Initial Report FDA Received Date: 03/18/2017
• Supplement Report FDA Received Date: 10/27/2017
• 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: Other; Required Intervention