MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT ADVANCED; EMBOLIZATION COIL

Model Number	8510-0206
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The coil remains implanted in the patient and the remainder of the device was discarded at the user facility; therefore, a product evaluation could not be performed.The root cause for the event cannot be determined.
Event or Problem Description
It was reported that after placement of an embolization coil in a left posterior communicating artery wide neck aneurysm, the coil did not fully detach.The coil was secured in the left internal carotid artery with two (2) additional stents.There was no reported patient injury related to the hypersoft coil.There were no focal deficits observed post-operatively and at the 6-month follow-up examination.

• Brand Name: HYPERSOFT ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6394122
• Report Number: 2032493-2017-00056
• Device Sequence Number: 10925156
• Product Code: HCG
• UDI-Device Identifier: 00811425027769
• UDI-Public: (01)00811425027769(11)160315(17)210315(10)160315V2
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K091641
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/07/2017

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: 03/15/2021
• Device Model Number: 8510-0206
• Device Lot Number: 160315V2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2017
• Initial Report FDA Received Date: 03/09/2017
• 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: Required Intervention
• Patient Age: 66 YR