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

Model Number	100619HFRM-V
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	03/10/2020
Type of Reportable Event	Malfunction
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 not returned to the manufacturer for evaluation.The root cause cannot be determined.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that during repositioning of an embolization coil in an anterior communicating artery aneurysm, the coil detached in the aneurysm.The entirety of the detached portion of the implant was inside of the aneurysm.There was no reported patient injury or additional intervention.
Additional Manufacturer Narrative
Clarification of event was provided.During placement of the coil in an a-com aneurysm after other coils had been previously implanted, an attempt was made to reposition the coil.During an attempt to remove the coil, it could not be removed from the previously implanted coils and detached in the aneurysm.No segment of the detached coil extended into the parent vessel.The detached implant coil remains implanted completely within the aneurysm.The pusher was removed from the patient without incident.The patient is reported to be "fine.".

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo, ca
• MDR Report Key: 9946915
• Report Number: 2032493-2020-00094
• Device Sequence Number: 2077171
• Product Code: HCG
• UDI-Device Identifier: 00816777023551
• UDI-Public: (01)00816777023551(11)190730(17)240630(10)1907305WF
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2020

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: 100619HFRM-V
• Device Catalogue Number: 100619HFRM-V
• Device Lot Number: 1907305WF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/10/2020
• Supplement Date Received by Manufacturer: 05/04/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1