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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. SOFIA 6F-125CM STR PERCUTANEOUS CATHETER

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MICROVENTION, INC. SOFIA 6F-125CM STR PERCUTANEOUS CATHETER Back to Search Results
Model Number MV-A6125ST
Device Problem Detachment of Device or Device Component (2907)
Patient Problems Paresis (1998); Thrombus (2101); Disability (2371); Foreign Body In Patient (2687)
Event Date 10/22/2019
Event Type  Injury  
Manufacturer Narrative

A search for non-conformances 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 has been returned for evaluation. The investigation is currently underway.

 
Event Description

It was reported that the patient presented with an acute cerebral infarction (ais) and mechanical thrombectomy was performed. During removal of a stent retriever (not an mv device) through the sofia after the 2nd thrombectomy pass, high resistance was felt. A 3rd aspiration was performed, resulting in successful removal of the thrombus and restoration of blood flow. Antiplatelet medication was administered. The day after the procedure, an mri demonstrated a metal artifact in the brain. After an unknown time period, the patient experienced another ais event and another thrombectomy was performed. The majority of the clot was removed from the middle cerebral artery (mca); however, some fragmented clot occluded the anterior cerebral artery and the distal mca. Feedback from the physician on (b)(6) 2020 confirmed that currently the patient's degree of disability is measured as mrs=5 with hemiparesis, and the patient is currently hospitalized. The physician stated that he does not directly relate the cause of the current patient's outcome with the "material" identified by the mra in the brain vessel.

 
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Brand NameSOFIA 6F-125CM STR
Type of DevicePERCUTANEOUS CATHETER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise drive
aliso viejo CA 92656
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key9625000
MDR Text Key189002531
Report Number2032493-2020-00014
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK150366
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/24/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/23/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberMV-A6125ST
Device LOT Number16082209
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/05/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/24/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured04/24/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/23/2020 Patient Sequence Number: 1
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