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

Model Number	8410-0258-A2
Medical Device Problem Codes	Detachment Of Device Component (1104); Stretched (1601)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/27/2017
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.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during the 4th repositioning of the embolization coil, the coil stretched and detached.A stent was used to affix the coil to the neck of the aneurysm.There was no reported patient injury.The patient's status is reported to be fine.
Additional Manufacturer Narrative
The pusher was returned for evaluation.The implant with the marker band was still attached to the distal heater coil with good tension.The implant coil remnant was found stretched about 10 mm and the distal portion was separated, and not returned, but the remnant of the proximal implant coil was still attached to the pusher.The stretch resistant monofilament, within the implant was broken.The body coil at the distal section appeared wavy.The pet transition appeared stretched based on the investigation, the report that the coil stretched and detached was confirmed.The implant coil was found stretched and the distal portion was separated and not returned, but a coil remnant, including the marker band, was still attached to the pusher, which was heavily damaged.The damage likely occurred during the multiple attempts to reposition the device in the aneurysm.The instruction for use state that if repositioning is difficult, the coil may become stretched and could possibly detach.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7133926
• Report Number: 2032493-2017-00336
• Device Sequence Number: 19048523
• Product Code: HCG
• UDI-Device Identifier: 00816777025128
• UDI-Public: (01)00816777025128(11)170707(17)220630(10)1707071W5
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K161452
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2017

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: Other
• Device Expiration Date: 06/30/2022
• Device Model Number: 8410-0258-A2
• Device Lot Number: 1707071W5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/27/2017
• Supplement Date Received by Manufacturer: 11/27/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 02/14/2018
• 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