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

Model Number	100206HS-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	09/27/2020
Type of Reportable Event	Serious Injury
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.The device was returned to the manufacturer for evaluation.The investigation is currently 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 coil embolization of a pcom aneurysm, the embolization coil unexpectedly detached from the delivery system.The detached implant coil was successfully removed from the patient with a stent retriever.There was no reported patient injury.
Additional Manufacturer Narrative
The implant coil was returned tangled with the stent used in the procedure and the pusher was not returned.As the pusher could not be evaluated, it cannot be determined if the implant separated from the pusher or if the implant was thermally detached using a detachment controller; therefore, the reported complaint cannot be confirmed.

• Brand Name: MICROPLEX HYPERSOFT HELICALVTA
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10760129
• Report Number: 2032493-2020-00314
• Device Sequence Number: 3334246
• Product Code: HCG
• UDI-Device Identifier: 00816777020628
• UDI-Public: (01)00816777020628(11)190805(17)240731(10)1908055WH
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K050954
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2020

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: 07/31/2024
• Device Model Number: 100206HS-V-A2
• Device Lot Number: 1908055WH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2020
• Initial Date Received by Manufacturer: 09/29/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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