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

Model Number	8510-0306
Medical Device Problem Codes	Detachment Of Device Component (1104); Difficult To Position (1467)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device has been returned; however, the evaluation is currently pending.Following completion of the investigation, a follow-up medwatch will be submitted.This device was used for treatment.
Event or Problem Description
It was reported that treatment was performed on an internal carotid aneurysm.After deployment of a stent, the last of several coils was difficult to place in the aneurysm.The microcatheter "kicked out" of position and the stent was re-crossed over the coil; however, a couple of loops were continuously falling out of the aneurysm.The coil eventually broke, leaving some of the coil in the parent artery.No additional intervention was attempted.The patient is reported to be doing well and was released without any deficits.

• Brand Name: HYPERSOFT ADVANCED HYPERSOFT
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 5953388
• Report Number: 2032493-2016-00224
• Device Sequence Number: 671376
• Product Code: HCG
• UDI-Device Identifier: 00811425027837
• UDI-Public: (01)00811425027837(11)151130(17)201130(10)151130VC1
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 11/30/2020
• Device Model Number: 8510-0306
• Device Lot Number: 151130VC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2016
• Initial Report FDA Received Date: 09/15/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENTERPRISE STENT; MICROCATHETER EXCELSIOR SL-10
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 25 YR
• Patient Weight: 195