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

Model Number	8410-0208-A2
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2017
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 was has not yet been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during repositioning of an embolization coil, the coil unexpectedly detached without use of the controller.The coil was retrieved with a snare device.There was no reported patient injury.The current patient's status is reported to be doing okay.
Additional Manufacturer Narrative
The device was returned without the implant for evaluation.The resistance of the system was noted to be within specification.The v-grip associated with the complaint was not returned; however, pusher passed the pretest with a new v-grip, showing a green light in all 4 angular locations.The body coil section after the pet transition, close to distal heater coil section, was noted to be wavy.The hypotube was visibly kinked in the middle section.The heater coil with pet covering was noted to be slightly compressed.The attachment monofilament demonstrated a stretched tail.Based on the investigation of the pusher and provided information, the complaint can be confirmed.The specific root cause of this complaint is unknown; however, the device exhibits evidence that it was subjected to tensile forces that exceeded its strength specifications.

• 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: 6909873
• Report Number: 2032493-2017-00248
• Device Sequence Number: 116457
• Product Code: HCG
• UDI-Device Identifier: 00816777025098
• UDI-Public: (01)00816777025098(11)170707(17)220630(10)1707071W5
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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: 8410-0208-A2
• Device Lot Number: 1707071W5
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/08/2017
• Supplement Date Received by Manufacturer: 09/08/2017
• Initial Report FDA Received Date: 10/03/2017
• Supplement Report FDA Received Date: 11/06/2017
• 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