MAUDE Adverse Event Report: MICROVENTION, INC. HYPERSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number	8410-0310-A2
Medical Device Problem Codes	Detachment Of Device Component (1104); Migration or Expulsion of Device (1395); Difficult To Position (1467); Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The coil remains implanted and the pusher wire was discarded at the user facility; therefore, a product evaluation could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that stent-assisted coiling was performed on a previously coiled anterior cerebral artery (aca) aneurysm.After implantation of several coils, the hypersoft 3d coil was placed; however, part of the coil was noted to be looping into the ipsilateral a2 artery.During an attempt to slowly remove the coil, the coil detached after approximately 10mm of the coil had been withdrawn.The pusher wire was removed and the jailed catheter with the coil inside was pulled back into the proximal aca.The coil loops that were noticed in the ipsilateral a2 were gone; however, the detached coil that was not jailed by the stent traveled to the middle cerebral artery (mca).A stent was implanted in the mca to trap the detached coil segment.There was no reported patient injury.The patient is reported to be doing well.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6324601
• Report Number: 2032493-2017-00037
• Device Sequence Number: 10936227
• Product Code: HCG
• UDI-Device Identifier: 00816777025159
• UDI-Public: (01)00816777025159(11)161220(17)211130(10)161220W5
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K071939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/11/2017

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: 11/29/2021
• Device Model Number: 8410-0310-A2
• Device Lot Number: 161220W5
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2017
• Initial Report FDA Received Date: 02/10/2017
• 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: ECHELON 10 MICROCATHETER; LVIS JR 2.5 X 13 STENT; LVIS JR 2.5 X 23 STENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR