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

Model Number	100206HS-V
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.A lot history trending review was performed and there were no similar complaints for this lot number.The pusher, microcatheter, and hub were returned for analysis.The implant, introducer, and dispenser hoop were not returned.The pusher was returned partially inside the microcatheter and hub.The proximal end of the pusher had sustained damage in multiple locations in the form of breaks and bends.The transition section of the pusher was broken, but the lead wires were still intact.It could not be determined if the damage was the result of shipping or if it occurred during use.The distal end of the pusher was found to be in the microcatheter and to have the body coil stretched from the hub on the catheter through the valve to the pusher.The microcatheter was found to be in good condition and without damage.No collapsing of the liner or damage to the braid was noted.The location where the distal tip of the pusher resided in the microcatheter did not exhibit signs of damage.The distal heater coil assembly was intact.The body coil was stretched and twisted upon return.The monofilament was extracted to determine the profile of the break.The profile exhibited some crushing and a slight tail.The monofilament was rebounded.190" into the heater coil assembly.Based on the investigation findings and available information, the reported complaint is confirmed.The implant was not returned and was detached from the pusher.The pusher was found to be severely stretched.The damage to the pusher did not allow for track testing within a microcatheter.No indicators were identified on the microcatheter that would indicate it was the root cause.Though it cannot be confirmed, the profile on the mono is indicative of a unit that was under tensile duress that likely underwent forces that exceed its specification.The root cause cannot be identified but appears to be related the retraction method during repositioning.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that during treatment of a left internal carotid artery aneurysm, the implant coil detached while being repositioned in the aneurysm.The detached implant was pushed into the aneurysm in its entirety using the delivery pusher of the device.There was no reported patient injury or intervention.

• Brand Name: MICROPLEX HYPERSOFT HELICALVTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8801046
• Report Number: 2032493-2019-00172
• Device Sequence Number: 11472818
• Product Code: HCG
• UDI-Device Identifier: 00816777020628
• UDI-Public: (01)00816777020628(11)190305(17)240229(10)1903055WH
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/18/2019

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: 02/29/2024
• Device Model Number: 100206HS-V
• Device Lot Number: 1903055WH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Initial Report FDA Received Date: 07/17/2019
• 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