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

Model Number	7110-0612-A2
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2021
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 was returned to the manufacturer for investigation.The investigation is ongoing.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complication associated with use of the device.
Event or Problem Description
It was reported that during treatment of a recurrent basilar tip aneurysm by coil embolization, an embolization coil implant was placed in the aneurysm but would not detach.The physician decided to remove the coil and the implant unexpectedly detached in the microcatheter.The delivery pusher was used to push the implant into the aneurysm.There was no reported intervention or patient injury.It was reported that the patient was successfully treated without sequelae and was discharged the following day.
Additional Manufacturer Narrative
The reported complaint is unconfirmed.The investigation of the returned coil system found the returned pusher with burn marks on the heater coil indicating the device was activated with a detachment v-grip controller.The unit was tested with the returned v-grip controllers and passed the 4-way continuity testing procedure; furthermore, the investigation found the pusher's monofilament with a mushroom shaped tip which is consistent with a successful detachment.The investigation of the returned device did not find any damage or other anomaly that would have caused or contributed to the reported complaint.

• Brand Name: HYDROFRAME 10 ADVANCED
• 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: 12698766
• Report Number: 2032493-2021-00423
• Device Sequence Number: 11873185
• Product Code: HCG
• UDI-Device Identifier: 00816777023698
• UDI-Public: (01)00816777023698(11)210608(17)260531(10)2106085PF
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2021

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: 05/31/2026
• Device Model Number: 7110-0612-A2
• Device Lot Number: 2106085PF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2021
• Supplement Date Received by Manufacturer: 10/08/2021
• Initial Report FDA Received Date: 10/26/2021
• Supplement Report FDA Received Date: 11/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2021
• 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
• Patient Sex: Female