MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 FRAMING COIL VTA; VASCULAR EMBOLIZATION DEVICE

Model Number	100931HFRM-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	10/21/2020
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 been returned to the manufacturer for evaluation.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 to treat an intracranial aneurysm, the embolization coil detached during advancement.The coil was removed in its entirety from the patient.There was no reported patient injury, or additional intervention.
Additional Manufacturer Narrative
The delivery pusher was returned for evaluation.The implant coil was confirmed to be detached from the pusher and was not returned.There was no evidence of thermal detachment on the pusher's heater coil.The monofilament exhibited a stretched tail shape at the tip, indicating that tensile forces were applied to the pusher, which caused the implant to detach; however, the exact source of the forces could not be determined.

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10878336
• Report Number: 2032493-2020-00340
• Device Sequence Number: 11710696
• Product Code: KRD
• UDI-Device Identifier: 00816777023605
• UDI-Public: (01)00816777023605(11)191022(17)240930(10)1910225PF
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100454
• 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: 09/30/2024
• Device Model Number: 100931HFRM-V-A2
• Device Catalogue Number: 100931HFRM-V
• Device Lot Number: 1910225PF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 11/23/2020
• Initial Report FDA Received Date: 11/20/2020
• Supplement Report FDA Received Date: 12/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1