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

Model Number	181445HFRM-V
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2021
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.Summary of device evaluation: the reported complaint is non-verifiable.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The pusher was the only component returned for evaluation.The investigation of the returned pusher found the implant to be separated from the pusher with no signs of activation at the heater coil.The investigation found the pusher's attachment monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive forces over specification.The reported complaint stated that the coil could not be advanced and stretched upon withdrawal; however, the investigation is unable to determine the cause of the reported complaint due to the missing components.The instructions for use (ifu) identifies difficult coil detachment and coil stretching as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that during a coil embolization procedure of a giant aneurysm on the right anterior cerebral artery (aca), difficult placement was encountered with the first coil.A second coil was used with the same microcatheter from a different manufacturer.The coil was advanced with 50% of the coil within the aneurysm when the coil became stuck within the microcatheter and could not be advanced and stretched upon withdrawal.The microcatheter and coil system were cut off at the proximal end.A snare was advanced over the microcatheter and all products were completely removed from the patient.Because of the size of the aneurysm, the decision was made to occlude the right common anterior artery.The occlusion was performed with good result and the patient had cross flow from the left.There was no report of injury to the patient, who was doing well.
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.Summary of device evaluation: the reported complaint is non-verifiable.The microcatheter used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint.The pusher was the only component returned for evaluation.The investigation of the returned pusher found the implant to be separated from the pusher with no signs of activation at the heater coil.The investigation found the pusher's attachment monofilament with a tensile break shape at the tip which is consistent with the device experiencing excessive forces over specification.The reported complaint stated that the coil could not be advanced and stretched upon withdrawal; however, the investigation is unable to determine the cause of the reported complaint due to the missing components.The instructions for use (ifu) identifies difficult coil detachment and coil stretching as a potential complication associated with the use of the device.
Event or Problem Description
It was reported that during a coil embolization procedure of a giant aneurysm on the right anterior cerebral artery (aca), difficult placement was encountered with the first coil.A second coil was used with the same microcatheter from a different manufacturer.The coil was advanced with 50% of the coil within the aneurysm when the coil became stuck within the microcatheter and could not be advanced and stretched upon withdrawal.The microcatheter and coil system were cut off at the proximal end.A snare was advanced over the microcatheter and all products were completely removed from the patient.Because of the size of the aneurysm, the decision was made to occlude the right common anterior artery.The occlusion was performed with good result and the patient had cross flow from the left.There was no report of injury to the patient, who was doing well.

• Brand Name: HYDROFRAME-18-AV
• Common Device Name: VASCULAR 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: 13021855
• Report Number: 2032493-2021-00494
• Device Sequence Number: 4626043
• Product Code: HCG
• UDI-Device Identifier: 00810170015182
• UDI-Public: (01)00810170015182(11)190722(17)240630(10)1907225R7
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K100454
• 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): 11/18/2021

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: 06/30/2024
• Device Model Number: 181445HFRM-V
• Device Catalogue Number: 181445HFRM-V
• Device Lot Number: 1907225R7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/22/2019
• 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: 63 YR
• Patient Sex: Female