BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REVIVE - THROMBECTOMY DEVICE

    MDR report key: 6503912 · Received April 19, 2017

    Report

    Report Number
    2954740-2017-00082
    Event Type
    Malfunction
    Date Received
    April 19, 2017
    Date of Event
    November 18, 2016
    Report Date
    March 30, 2017
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    DXE
    UDI-DI
    00878528000006
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: GUIDING CATHETER (8FR OPTIMO, TOKAI MEDICAL PRODUCT), MICRO CATHETER (MARKSMAN, COVIDIEN MEDICAL), PENUMBRA THROMBECTOMY DEVICE. CONCLUSION: THE DEVICE WAS NOT RETURNED. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. CONTINUED TOTAL OCCLUSION IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE USE OF THE REVIVE SE. THE ROOT CAUSE OF THE EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, PROCEDURAL/PATIENT FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. AS PER THE IFU: ¿CONTRAINDICATIONS FOR THIS DEVICE INCLUDE EXTREME VESSEL TORTUOSITY OR OTHER CONDITIONS PREVENTING THE ACCESS OF THE DEVICE¿. THE IFU ALSO WARNS THAT ¿IF THE REVIVE SE DEVICE IS UNABLE TO REACH OR CROSS THE OCCLUSION, THE PROCEDURE SHOULD BE TERMINATED.¿ HEMORRHAGE AND STROKE ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE REVIVE SE. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED; HOWEVER, PATIENT AND PHARMACOLOGIC FACTORS MAY HAVE CONTRIBUTED TO THE EVENT. THE PATIENT HAD PRESENTED WITH NEUROLOGICAL SYMPTOMS AND RECEIVED THROMBOLYTIC TREATMENT DURING THE PROCEDURE WHICH COULD INCREASE THE LIKELIHOOD OF DEVELOPING HEMORRHAGIC TRANSFORMATION. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE REVIVE SE IS NOT DISTRIBUTED IN THE U.S.; HOWEVER, IS SIMILAR TO THE REVIVE PV THAT IS DISTRIBUTED IN THE U.S. THIS IS AN INITIAL/FINAL MDR REPORT.

    Description of Event or Problem · 1

    AS REPORTED VIA THE REVIVE SE PMS (B)(4) (PATIENT NUMBER (B)(6)), THE REVIVE SE (FRS21452299/ S10649) DID NOT FULLY REMOVE THE THROMBUS, AND THE PATIENT EXPERIENCED ASYMPTOMATIC INTRACRANIAL BLEEDING AT THE TARGET AREA 24 HOURS AFTER THE PROCEDURE. THE PATIENT HAD PRESENTED ON (B)(6) 2016 WITH ACUTE STAGE CEREBRAL INFARCTION DEVELOPED IN THE DISTAL PORTION OF INTERNAL CAROTID ARTERY RIGHT MIDDLE CEREBRAL ARTERY WITH OCCLUSION (M1). ON (B)(6) 2016, PRE-OP ASPECTS-CT WAS 9 POINTS, NIHSS WAS 14 POINTS, TICI WAS 0 POINTS. THE DIAMETER OF THE OCCLUDED VESSEL WAS 2.5 MM AT THE PROXIMAL PORTION AND 2 MM AT THE DISTAL PORTION. THE LENGTH OF THE OCCLUDED VESSEL WAS 15 MM. NO T-PA WAS ADMINISTERED. THE REVIVE SE WAS DEPLOYED ONCE AT THE TARGET LESION, AND ANOTHER THROMBECTOMY DEVICE (PENUMBRA 4 MAX) WAS DEPLOYED TWICE, RESULTING IN TICI 2A. THE REVIVE SE WAS DEPLOYED ONE MORE TIME IN THE TARGET LESION AND TICI REMAINED 2A. THE GUIDING SYSTEM WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED. POSTOPERATIVE NIHSS WAS 14 POINTS. APPROXIMATELY 24 HOURS AFTER THE PROCEDURE, ASYMPTOMATIC INTRACRANIAL BLEEDING DEVELOPED IN THE TARGET LESION AREA. ON (B)(4) 2016, MRS WAS 4 POINTS, NIHSS WAS 8 POINTS, ASPECT-CT WAS 5 POINTS, AND ASPECT-DWI WAS 6 POINTS. ON (B)(6) 2016, IT WAS CONFIRMED BY MRI THAT THE ASYMPTOMATIC INTRACRANIAL BLEEDING HAD DISAPPEARED. ON (B)(6) 2017: MRS WAS 3 POINTS. THE DEVICE WAS NOT AVAILABLE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286259 REVIVE - THROMBECTOMY DEVICE EMBOLECTOMY CATHETER DXE MEDOS INTERNATIONAL SARL NA S10649 00878528000006

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR