MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME 10 FRAMING COIL VTA; VASCULAR EMBOLIZATION DEVICE

Model Number	100612HFRM-V-A2
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	05/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an embolization treatment of a right media aneurysm on (b)(6) 2021 four hydroframe-10 av coils were deployed without incident.On (b)(6) 2021 imaging revealed some small micro-infarcts.The patient was reported in good condition without permanent neurological damage.No secondary intervention was taken and no sequelae was reported.
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 was thus not available for evaluation.However, procedure imaging was provided for review.There are 3 subtracted dsa coned-down images of a right ica angiogram.One shows an approximately 7 mm right mca bifurcation aneurysm.The other two are obliques that show the final result after coiling the aneurysm.There are some loops of coils protruding slightly into the parent artery; the imaging does not display evidence of a clot.The last image is a set of mri axial images at the mid-level of the brain demonstrating infarcts in the right basal ganglia and caudate nucleus, as well as multiple small infarcts in the distal mca territory.Since the physical device was not able to be evaluated, the investigation could not determine if a condition existed that would have caused or contributed to the reported event.
Additional Manufacturer Narrative
H11: corrections: h6: medical device problem code.H6: remove code 2993 from the initial report.

• Brand Name: HYDROFRAME 10 FRAMING COIL VTA
• Common Device Name: VASCULAR 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: 13741184
• Report Number: 2032493-2022-00083
• Device Sequence Number: 11969291
• Product Code: KRD
• UDI-Device Identifier: 00816777023544
• UDI-Public: (01)00816777023544(11)200608(17)250531(10)2006085WF
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K090357
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 02/09/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Model Number: 100612HFRM-V-A2
• Device Catalogue Number: 100612HFRM-V
• Device Lot Number: 2006085WF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2022
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/11/2022
• Supplement Report FDA Received Date: 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown