MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL REGULAR VTA; ARTIFICIAL EMBOLIZATION DEVICE

Model Number	MV-BCA41015
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	01/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided.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.The device has been returned to the manufacturer for evaluation.The investigation is underway.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of a posterior communicating artery aneurysm, an embolization coil unexpectedly detached in the microcatheter during repositioning.The coil was removed in its entirety together with the microcatheter.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
Only the pusher was returned for analysis.The implant, and microcatheter were not returned.Investigation into the returned device found the proximal end of the pusher to be in good condition.The distal end of the pusher was also in good condition, except for the distal body coil.The body coil was found to be overlapped in multiple locations near the distal platinum marker.The pusher's electrical resistance was found to be 40.9 ohms, which is within the specification.The implant was not attached and the supplementary parts were not returned for analysis.The unit was dissected to expose the monofilament.The monofilament was found to have been broken at the attachment area.Inspection of the pusher found overlapping body coils near the distal end, and the monofilament displayed a profile that is consistent with a tensile separation (i.E.Retraction/tensile forces that exceeded the strength of the monofilament), rather than detachment using a detachment controller.The origin of the tensile force cannot be determined.The implant and microcatheter were not returned, so the investigation could not determine if either component caused or contributed to the reported event.

• Brand Name: MICROPLEX HELICAL REGULAR VTA
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 9708991
• Report Number: 2032493-2020-00028
• Device Sequence Number: 3474558
• Product Code: HCG
• UDI-Device Identifier: 00816777021991
• UDI-Public: (01)00816777021991(11)181212(17)231130(10)1812125WE
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2020

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: 11/30/2023
• Device Model Number: MV-BCA41015
• Device Lot Number: 1907235YX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2020
• Initial Date Received by Manufacturer: 01/15/2020
• Supplement Date Received by Manufacturer: 02/03/2020
• Initial Report FDA Received Date: 02/13/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1