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

Model Number	8410-0408
Medical Device Problem Codes	Detachment Of Device Component (1104); Stretched (1601); Separation Failure (2547)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.The coil remains implanted; however, the pusher wire was returned for evaluation.The v-grip used for the procedure was not returned.The pusher wire was kinked at several locations.The implant coil was detached and missing from the pusher, although a small portion of the implant coil remained attached to the pusher wire at the detachment zone.The detached coil was stretched at the proximal end tie knot area.The gold connector end was found to be detached inside the introducer.The introducer was cut open to retrieve the gold connector.The connector appeared to be smashed.There appeared to be some corrosion present close to the solder.The black pet at the transition section was broken and the lead wires were exposed.Destructive analysis on the distal black pet revealed the lead wires were securely attached to the solder joints.There was no evidence of thermal detachment.Results of the product evaluation demonstrated a broken connector, which would have prevented detachment of the implant coil from the pusher due to the presence of an open circuit; however, it is unknown how or when the damage to the connector occurred.Implant coils were still present on the pusher wire and there was no evidence of thermal detachment.The v-grip used for the case was not returned; therefore, analysis of the v-grip and functional testing could not be performed.Based on the reported procedure details and the product evaluation, the complaints of coil non-detachment, coil stretch, and coil break can be confirmed; however, the root cause of the non-detachment cannot be determined.
Event or Problem Description
It was reported that after positioning an embolization coil in an aneurysm, the coil would not detach.Multiple attempts were made to detach the coil, without success.During removal, the coil stretched and detached.The coil was pushed back into the aneurysm without incident.There was no reported patient injury.The current patient's status is reported to be good.

• Brand Name: HYPERSOFT 3D ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 1311 valencia avenue; tustin CA 92780
• MDR Report Key: 6386343
• Report Number: 2032493-2017-00057
• Device Sequence Number: 501360
• Product Code: HCG
• UDI-Device Identifier: 00811425028094
• UDI-Public: (01)00811425028094(11)160107(17)210107(10)160107VC1
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 02/05/2017

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: Other
• Device Expiration Date: 01/07/2021
• Device Model Number: 8410-0408
• Device Lot Number: 160107VC1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2017
• Initial Report FDA Received Date: 03/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 60 YR