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

Model Number	100720HFIL-V-A2
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/10/2021
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 device was not returned to the manufacturer for evaluation; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc.Will issue a supplemental mdr report.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 procedure of an aneurysm the coil was reported to have detached inside the microcatheter.The coil was partially within the aneurysm and the microcatheter.The catheter was withdrawn and the coil was removed using a tiger retriever.The procedure was completed with additional coils.The patient was reported to be doing well.No patient injury was incurred.
Additional Manufacturer Narrative
H10: evaluation summary: 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 stretched tail 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.

• 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: 12450833
• Report Number: 2032493-2021-00366
• Device Sequence Number: 12012740
• Product Code: HCG
• UDI-Device Identifier: 00816777024428
• UDI-Public: (01)00816777024428(11)201209(17)251130(10)2012091W5
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2021

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: 11/30/2025
• Device Model Number: 100720HFIL-V-A2
• Device Catalogue Number: 100720HFIL-V
• Device Lot Number: 2012091W5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2021
• Initial Date Received by Manufacturer: 08/10/2021
• Supplement Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 09/09/2021
• Supplement Report FDA Received Date: 10/13/2021
• 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