MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX COMPLEX 10 VTA; ARTIFICIAL EMBOLIZATION DEVICE

Model Number	100307CC-V-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformance 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.Only the coil pusher was received for evaluation.The pusher was broken at the hypotube/body coil transition section of the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification during the procedure.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 a coil embolization treatment, the coil delivery system unexpectedly detached.There was no reported patient injury or additional intervention.The current condition of the patient is reported to be "good.".

• Brand Name: MICROPLEX COMPLEX 10 VTA
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10618260
• Report Number: 2032493-2020-00271
• Device Sequence Number: 19513027
• Product Code: HCG
• UDI-Device Identifier: 00816777021342
• UDI-Public: (01)00816777021342(11)190703(17)240630(10)1907035WX
• Combination Product (Y/N): N
• Initial Reporter Country: KZ
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2020

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: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: 100307CC-V-A2
• Device Lot Number: 1907035WX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 10/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 46 YR