MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFRAME-10-AV; COILS

Model Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/24/2020
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 not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.The instructions for use (ifu) identifies thromboembolic events as potential complications associated with use of the device.
Event or Problem Description
As reported from the rage clinical study, event term : thromboembolic event, perfusion deficit observed.Event #: 4, post operative days: 0 days.It was reported that during procedure.Decision was made to attempt thromboaspiration within the left a1-a2.A 3 max catheter was then advanced over the synchro wire and advanced into the anterior communicating complex.Angiography through the 3 max catheter at the level of the anterior communicating artery complex was performed demonstrating good filling of the right a2 branch and sluggish flow within the left a2.At this time the patient had a brief episode of hypertension, and whole head angiography was repeated, showing no evidence of extravasation or aneurysm rupture and improved flow within the left a1 and a2 branches.Due to improved flow to the left aca, no further attempts to access the left distal aca was performed.The event was indicated to probably related to the study device and definitely related to the study procedure.Ae outcome: resolved without sequelae.
Additional Manufacturer Narrative
Correction was made to section a1- should be, (b)(6).
Event or Problem Description
A supplemental report is being submitted to make correction to typographical error in section a1.The correct patient identifier reference should be (b)(6), not (b)(6).

• Brand Name: HYDROFRAME-10-AV
• Common Device Name: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 18636072
• Report Number: 2032493-2024-00100
• Device Sequence Number: 7930356
• Product Code: KRD
• UDI-Device Identifier: 00816777023667
• UDI-Public: (01)00816777023667(11)191016(17)240930(10)1910165WF
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2024

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: 09/30/2024
• Device Model Number: UNKNOWN
• Device Lot Number: 1910165WF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2024
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• 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 Age: 61 YR
• Patient Sex: Female