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

Model Number	181644HFRM-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	05/31/2021
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.The device was returned to the manufacturer for analysis; however, investigation is not complete and still ongoing.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.
Event or Problem Description
It was reported that an embolization coil unexpectedly detached during deployment in an acute basilar tip aneurysm procedure.A snare device was used to successfully retrieved the coil.There was no report of injury to the patient.

• Brand Name: HYDROFRAME FRAMING COIL
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12096662
• Report Number: 2032493-2021-00255
• Device Sequence Number: 4898267
• Product Code: HCG
• UDI-Device Identifier: 00816777023872
• UDI-Public: (01)00816777023872(11)191212(17)241130(10)1912121W7
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K100454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/31/2021

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: Health Professional
• Device Expiration Date: 11/30/2024
• Device Model Number: 181644HFRM-V-A2
• Device Catalogue Number: 181644HFRM-V
• Device Lot Number: 1912121W7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2021
• Initial Report FDA Received Date: 06/30/2021
• 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