MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100930HFIL-V-A2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an embolization treatment of a ruptured giant acom aneurysm (12mm), the second coil was a hydrofill 9x30.The coil was pushed through a prowler 14 microcatheter.Approximately 50% of the coil was inside the aneurysm and resistance was encountered.It was decided to withdraw the coil.During the withdraw maneuver, the coil detached from the delivery pusher partially within the aneurysm and the microcatheter.The coil was successfully removed using a snare over the transfemoral sheath.Additional coils were place with good result.The patient was reported to be intubated on icu.
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 was discarded by user facility and not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed at this time.The instructions for use (ifu) identifies premature coil detachment as potential complication a associated with use of the device.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14094804
• Report Number: 2032493-2022-00153
• Device Sequence Number: 20248182
• Product Code: HCG
• UDI-Device Identifier: 00816777023315
• UDI-Public: (01)00816777023315(11)201106(17)251031(10)2011061W5
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2022

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: 10/31/2025
• Device Model Number: 100930HFIL-V-A2
• Device Catalogue Number: 100930HFIL-V
• Device Lot Number: 2011061W5
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2022
• Initial Report FDA Received Date: 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown