MAUDE Adverse Event Report: MICROVENTION, INC HYDROFRAME 10 ADVANCED; EMBOLIZATION COIL

Model Number	7110-0415-A2
Medical Device Problem Codes	Separation Failure (2547); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.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 implant, pusher, introducer, and dispenser hoop were returned for analysis.Investigation into the returned components found the introducer to be in good condition and without damage.As received, the coil was found to be severely stretched and detached from the pusher.Further inspection of the pusher found that the lead wires were damaged and severed at the distal pusher area due to the severe stretching.Due to the damage, the electrical continuity could not be measured.Additionally, the monofilament end looked damaged, which is consistent with devices that experience tensile breaks.Upon inspection of the heater coil, no burn marks were found, which would indicate a thermal detachment.The heater coil showed no signs of activation, and the pusher coil was severely stretched, which severed the lead wires.The monofilament profile indicates the implant separated due to tensile forces.The inspection of the device could not determine if the lead wires were severed during the procedure, but this condition prevents thermal detachment.The physical evaluation of the device could not identify the conditions or circumstances that led to the damages to the pusher, 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 stent-assisted coiling of an anterior communicating artery aneurysm, an embolization coil implant would not detach.When the coil was being removed, it unexpectedly detached and some of the coil extended into the parent vessel.Another stent was implanted to affix the coil to the vessel wall.There was no reported patient injury.The patient is reported to be doing well.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 9508112
• Report Number: 2032493-2019-00297
• Device Sequence Number: 1878477
• Product Code: HCG
• UDI-Device Identifier: 00816777025258
• UDI-Public: (01)00816777025258(11)190529(17)240430(10)1905291WF
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/25/2019

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: Other
• Device Expiration Date: 05/31/2024
• Device Model Number: 7110-0415-A2
• Device Lot Number: 1905291WF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention