MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; NEUROVASCULAR EMBOLIZATION DEVICE

Model Number	100510HFIL-V-A2
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A search for non-conformances associated with the reported 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 available for return to the manufacturer for analysis but has not been received yet.Therefore, the alleged product issue cannot be confirmed.If the device or new information is received, microvention inc.Will submit a supplemental report.The instructions for use (ifu) identifies premature and difficult or delayed coil detachment as potential complication associated with use of the device.
Event or Problem Description
It was reported that the embolization coil was used to treat a patient with a pre-ruptured aneurysm.After positioning a microcatheter into the aneurysm sack, the physician started deploying coils.A framing coil was first placed followed by the hydrofill coil that encountered resistance inside the microcatheter.During attempt to pull back, the coil unintentionally detached inside the microcatheter.Consequently, the ruptured aneurysm was treated.Reportedly, the patient was left with some non-specified deficits.
Additional Manufacturer Narrative
Additional information received.The physician indicated deficits could not be specified as the patient came in with a ruptured aneurysm with some deficits.The case was completed with other hydro coils.Patient was transferred to another hospital with no update of status.The device has not yet been returned to the manufacturer.
Additional Manufacturer Narrative
Additional information: h6, h10 (summary device evaluation).Summary device evaluation: the investigation of the coil system found the implant returned separated from the delivery system.The monofilament was found to experience a tensile break based on the profile of the tip.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: HYDROFRAME-10-AV
• 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: 14853380
• Report Number: 2032493-2022-00249
• Device Sequence Number: 17533465
• Product Code: HCG
• UDI-Device Identifier: 00816777023292
• UDI-Public: (01)00816777023292(11)220322(17)270228(10)0000171561
• Combination Product (Y/N): N
• Initial Reporter Country: LO
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 100510HFIL-V-A2
• Device Catalogue Number: 100510HFIL-V
• Device Lot Number: 0000171561
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 07/01/2022; 08/19/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 07/15/2022; 08/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 90 KG