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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED)

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MICROVENTION, INC. FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED) Back to Search Results
Model Number FRED3516-PMA
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Patient Problems Speech Disorder (4415); Thrombosis/Thrombus (4440)
Event Date 04/15/2021
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 was implanted in the patient and not available for return to the manufacturer for analysis. The investigation is ongoing.
 
Event Description
It was reported that the procedure was a flow diversion of the right ica. The procedure was on label and proctored by the physician. The patient was on dapt therapy with a pru in optimal range measured just prior to procedure. The procedure was unremarkable with no peri-procedural complications. Several hours after procedure, the physician noticed patient abnormalities (mild expressive aphasia) during exam in post-operative icu. The patient was taken back to ir for intervention to perform angiography. Clot formation was noticed near the fred device during angiography, thrombectomy was attempted. In addition, the physician noticed the implanted fred device had experienced proximal foreshortening and/or slight distal migration. The physician attempted clot aspiration with no success. An attempt to cross the fred flow diverter with multiple devices with no success. The patient was treated with integrilin with a plan to switch patient from plavix / aspirin to brillinta / aspirin. Patient experienced mild expressive aphasia.
 
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Brand NameFLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED)
Type of DeviceFRED
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise
aliso viejo, CA 92656
7142478000
MDR Report Key11828705
MDR Text Key250864579
Report Number2032493-2021-00211
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRED3516-PMA
Device Lot Number20061755J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/17/2020
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: 05/14/2021 Patient Sequence Number: 1
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