MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 ADVANCED; VASCULAR EMBOLIZATION DEVICE

Model Number	100415HFRM-V-A2
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/20/2021
Type of Reportable Event	Serious Injury
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 implanted in the patient and not returned to the manufacturer for evaluation.Therefore, the alleged product issue could not be confirmed.The instructions for use (ifu) identifies premature coil detachment and clot formation as potential complications associated with use of the device.
Event or Problem Description
It was reported that during a treatment of an mca aneurysm, the coil stretched during positioning and detached from the delivery pusher.Thrombus formation was reported.Tirofiban was administered and the thrombus was lysed.No patient harm was reported.The patient is reported to be "well off.".
Additional Manufacturer Narrative
Additional information received indicating that during implantation procedure, a small part of the coil end was protruding in the parent vessel and was pushed inside the aneurysm.

• Brand Name: HYDROFRAME 10 ADVANCED
• Common Device Name: VASCULAR EMBOLIZATION DEVICE
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 12029071
• Report Number: 2032493-2021-00242
• Device Sequence Number: 16991328
• Product Code: KRD
• UDI-Device Identifier: 00816777026217
• UDI-Public: (01)00816777026217(11)200702(17)250630(10)2007025PF
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• 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): 05/20/2021

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: 06/30/2025
• Device Model Number: 100415HFRM-V-A2
• Device Catalogue Number: 100415HFRM-V
• Device Lot Number: 2007025PF
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/18/2021
• Supplement Report FDA Received Date: 07/16/2021
• 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