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

Model Number	100415HFRM-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	04/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 stated to be available for analysis but has not yet been returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device is received, the investigation will be performed, and a supplemental report will be submitted.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 during the embolization treatment, the implant coil unintentionally detached during retraction into the distal end of the microcatheter.A snare device was used to remove the coil from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Additional information was received indicating the coil stretched.The physician lost 1:1 haptic feedback from the pusher and implant.Upon retrieving the pusher, it was noted that the coil did not respond and then it felt as if the sr element had broken with the implant stretching out.A solitaire stent was used to grab the implant and removed from the sac.Detachment was never attempted as the coil lost 1:1 response whilst being redeployed.The pusher was pulled back but the implant did not follow it.The device has not been returned to the manufacture of the time of this report.If the device is returned a supplemental report will be issued at the conclusion of the evaluation.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6, h10 (summary device evaluation).Summary device evaluation: the investigation of the returned coil system found the pusher coil damaged, the proximal connector bent, and the implant severely stretched and separated from the pusher.No indication using a detachment controller was found on the pusher's heater coil.The investigation found the pusher's monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive force that exceeded the strength of the monofilament causing the implant to separate from the pusher.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.

• 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; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 14459768
• Report Number: 2032493-2022-00195
• Device Sequence Number: 4686024
• Product Code: HCG
• UDI-Device Identifier: 00816777026217
• UDI-Public: (01)00816777026217(11)210929(17)260831(10)0000093209
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/02/2022

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: 08/31/2026
• Device Model Number: 100415HFRM-V-A2
• Device Catalogue Number: 100415HFRM-V
• Device Lot Number: 0000093209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2022
• Supplement Date Received by Manufacturer: 05/08/2022; 07/18/2022
• Initial Report FDA Received Date: 05/20/2022
• Supplement Report FDA Received Date: 06/07/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female