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

Model Number	7118-2048-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Stroke/CVA (1770); Ruptured Aneurysm (4436)
Date of Event	11/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 pusher was the only component received for evaluation.The investigation of the returned coil system found the implant to be 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.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 an elective procedure on giant right mca aneurysm, the first embolization coil implant placed in the aneurysm unexpectedly detached.The implant was entirely within the aneurysm.There was an intra-procedural rupture during the case.It is not known how the rupture occurred and a competitor's coils were used as well.Protamine was administered and a balloon was utilized to arrest bleeding.The patient's status was reported to be "good" after the procedure.Later the patient was reported to be dysarthric, likely from a right frontal stroke, and should likely recover with time and rehab.The physician stated that it is probable that a small plaque caused an embolism when accessing the carotid origins.
Additional Manufacturer Narrative
A search for non-conformance 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 pusher was the only component received for evaluation.The investigation of the returned coil system found the implant to be 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.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 an elective procedure on giant right mca aneurysm, the first embolization coil implant placed in the aneurysm unexpectedly detached.The implant was entirely within the aneurysm.There was an intra-procedural rupture during the case.It is not known how the rupture occurred and a competitor's coils were used as well.Protamine was administered and a balloon was utilized to arrest bleeding.The patient's status was reported to be "good" after the procedure.Later the patient was reported to be dysarthric, likely from a right frontal stroke, and should likely recover with time and rehab.The physician stated that it is probable that a small plaque caused an embolism when accessing the carotid origins.

• Brand Name: HYDROFRAME 18 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: 13014033
• Report Number: 2032493-2021-00489
• Device Sequence Number: 19286760
• Product Code: HCG
• UDI-Device Identifier: 00816777024039
• UDI-Public: (01)00816777024039(11)210701(17)260630(10)2107011W7
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/17/2021

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: 06/20/2026
• Device Model Number: 7118-2048-A2
• Device Lot Number: 2107011W7
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2021
• 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; Other
• Patient Sex: Female