MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL 10 ADVANCED; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100615HFIL-V-A2
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2021
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 investigation of the returned coil system found the implant to be separated from the pusher with no signs of activation.The pusher's heater coil was found damaged/compressed with the monofilament protruding from the heater coil.The monofilament profiles a stretched tail shape at the tip, indicating the device was experiencing excessive force that exceeded the strength of the monofilament, causing the implant to separate from the pusher.The investigation found the returned microcatheter cut into three pieces.The microcathetesger was investigated under x-ray and found the implant to be broken and stretched in the three parts of the microcatheter.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 detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during a coil embolization, the coil stretched and prematurely detached in the vessel.The coil was retrieved with an endovascular snare.The patient was reported to be fine.

• Brand Name: HYDROFILL 10 ADVANCED
• Common Device Name: NEUROVASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 11712773
• Report Number: 2032493-2021-00149
• Device Sequence Number: 3591015
• Product Code: HCG
• UDI-Device Identifier: 00816777024404
• UDI-Public: (01)00816777024404(11)191202(17)241130(10)1912021W5
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K113457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2021

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: 11/30/2024
• Device Model Number: 100615HFIL-V-A2
• Device Catalogue Number: 100615HFIL-V
• Device Lot Number: 1912021W5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/23/2021
• 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