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

Model Number	100928CMSR-V-A
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	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 not yet been returned to the manufacturer for analysis.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 an aneurysm, the embolization coil detached from the delivery pusher during removal from the microcatheter.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
The investigation of the returned coil system revealed the implant coil was attached to the pusher with no signs of thermal detachment.The alleged coil detachment was not confirmed.

• Brand Name: MICROPLEX COMPASS COMPLEX VTA
• Common Device Name: ARTIFICIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10932944
• Report Number: 2032493-2020-00365
• Device Sequence Number: 19495411
• Product Code: HCG
• UDI-Device Identifier: 00812636021232
• UDI-Public: (01)00812636021232(11)150912(17)200912(10)150912V2
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/22/2020

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: 09/12/2020
• Device Model Number: 100928CMSR-V-A
• Device Catalogue Number: 100928CMSR-V
• Device Lot Number: 150912V2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1