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

Model Number	100515HFRM-V-A2
Medical Device Problem Codes	Stretched (1601); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformances 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 return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Event or Problem Description
As reported: it was identified that when a 5x15 hydroframe coil was placed, it had apparently released without having been completely implanted, since a large part of the device was still in the microcatheter during a cerebral aneurysm occlusion procedure in the bifurcation of the middle cerebral artery.The doctor managed to extract it using his own technique and upon removing it, it was evident that it had lengthened and this prevented its proper placement.The procedure ends without affecting the patient.Patient is fine.
Additional Manufacturer Narrative
Items returned: n/a.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform an analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances 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.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review: potential complications: potential complications include, but are not limited to: hematoma at the site of entry, vessel perforation, aneurysm rupture, parent artery occlusion, incomplete aneurysm filling, emboli, hemorrhage, ischemia, vasospasm, coil migration or misplacement, premature or difficult coil detachment, clot formation, revascularization, post-embolization syndrome, and neurological deficits including stroke and possibly death.Cases of chemical aseptic meningitis, edema, hydrocephalus and/or headaches have been associated with the use of embolization coils in the treatment of large and giant aneurysms.The physician should be aware of these complications and instruct patients when indicated.Appropriate patient management should be considered.Warnings and precautions: the hes is intended for single use only.Do not resterilize and/or reuse the device.After use, dispose in accordance with hospital, administrative and/or local government policy.Do not use if the packaging is breached or damaged.If a coil must be retrieved from the vasculature after detachment, do not attempt to withdraw the coil with a retrieval device, such as a snare, into the delivery catheter.This could damage the coil and result in device separation.Remove the coil, microcatheter, and any retrieval device from the vasculature simultaneously.Detachment of the hes coil: 33.When the v grip® detachment controller is properly connected to the v trak® delivery pusher, a single audible tone will sound and the light will turn green to signal that it is ready to detach the coil.If the detachment button is not pushed within 30 seconds, the solid green light will slowly flash green.Both flashing green and solid green lights indicate that the device is ready to detach.If the green light does not appear, check to ensure that the connection has been made.If the connection is correct and no green light appears, replace the v grip® detachment controller.35.Push the detachment button.When the button is pushed, an audible tone will sound and the light will flash green.36.At the end of the detachment cycle, three audible tones will sound and the light will flash yellow three times.This indicates that the detachment cycle is complete.If the coil does not detach during the detachment cycle, leave the v grip® detachment controller attached to the v trak® delivery pusher and attempt another detachment cycle when the light turns green.37.The light will turn red after the number of detachment cycles specified on the v grip® labeling.Do not use the v grip® detachment controller if the light is red.Discard the v grip® detachment controller and replace it with a new one when the light is red.38.Verify detachment of the coil by first loosening the rhv valve, then pulling back slowly on the delivery system and verifying that there is no coil movement.If the implant did not detach, do not attempt to detach it more than two additional times.If it does not detach after the third attempt, remove the delivery system.The physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.
Event or Problem Description
As reported: it was identified that when a 5x15 hydroframe coil was placed, it had apparently released without having been completely implanted, since a large part of the device was still in the microcatheter during a cerebral aneurysm occlusion procedure in the bifurcation of the middle cerebral artery.The doctor managed to extract it using his own technique and upon removing it, it was evident that it had lengthened and this prevented its proper placement.The procedure ends without affecting the patient.Patient is fine.
Event or Problem Description
As reported: it was identified that when a 5x15 hydroframe coil was placed, it had apparently released without having been completely implanted, since a large part of the device was still in the microcatheter during a cerebral aneurysm occlusion procedure in the bifurcation of the middle cerebral artery.The doctor managed to extract it using his own technique and upon removing it, it was evident that it had lengthened and this prevented its proper placement.The procedure ends without affecting the patient.Patient is fine.
Additional Manufacturer Narrative
Items returned for evaluation: pusher; implant; dispenser hoop.Items not returned for evaluation: introducer; microcatheter.The visual analysis of the returned device found that the implant was not attached to the pusher, and the pusher exhibited kinks at the proximal connector.The implant was returned stretched at the proximal section, damaged, and separated from the pusher.The investigation found the pusher's monofilament to have a mushroom profile, which indicates that the implant experienced thermal activation using a detachment controller.The investigation of the returned coil system found the pusher kinked at the proximal connector, and the implant stretched at the proximal section, damaged, and separated from the pusher.The visual inspection of the attached monofilament found evidence of thermal detachment, which indicates the implant detached electrically.Though the investigation was able to confirm the implant detached, the evaluation of the coil system alone could not definitively determine when or where the coil detachment occurred (i.E., inside/outside the microcatheter).The physical evaluation of the device could not identify the conditions or circumstances that led to the pusher and implant damage, but the damage is consistent with the device experiencing forces exceeding the pusher and implant's yield strength.The microcatheter used in the procedure was not returned for evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 20043218
• Report Number: 2032493-2024-00627
• Device Sequence Number: 7970852
• Product Code: KRD
• UDI-Device Identifier: 00812636023533
• UDI-Public: (01)00812636023533(11)230131(17)271231(10)0000317294
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K090357
• 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): 11/22/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 100515HFRM-V-A2
• Device Lot Number: 0000317294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 09/26/2024; 11/18/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/27/2024; 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2023
• 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: 75 YR
• Patient Sex: Female