MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-18-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	7118-1139-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a stent-assisted coiling procedures to treat a 13.5mm basilar tip aneurysm, the physician had placed 2 non-microvention stents one each in both pcas.Three hydroframe coils were then placed.The fourth coil was going into the coil mass and primarily filling the anterior portion of the aneurysm.The physician began to pull the coil back out and was met with resistance and the coil prematurely detached as the belief that it was caught in the coil mass.About 20mm of coil was protruding all of the way down into the vertebral artery.A snare was not available to remove the coil and physician used 4 stents to tack down the stretched coil.At the vertebral artery the diameter of the vessel was over 5.5mm and the most proximal portion of the coil needed to be tacked down with a larger carotid stent.Due to tortuosity, it was unable to get the carotid stent in place and about 5mm of coil remained free floating in the vertebral artery and the procedure was concluded.The patient was discharged and is in stable condition and is on dapt per standard protocol.No additional interventions planned or needed.
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 implanted in the patient and is not available for return to the manufacturer for evaluation.Therefore, the alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.

• Brand Name: HYDROFRAME-18-AV
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terry callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15685829
• Report Number: 2032493-2022-00410
• Device Sequence Number: 6444051
• Product Code: HCG
• UDI-Device Identifier: 00816777023971
• UDI-Public: (01)00816777023971(11)220207(17)270131(10)0000155701
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K100454
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/12/2022

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 Model Number: 7118-1139-A2
• Device Lot Number: 0000155701
• 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: 10/12/2022
• Initial Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2022
• 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 Age: 76 YR
• Patient Sex: Female