BEUDAMED
    FDA Adverse Event Death Summary report: N

    REACT CATHETER

    MDR report key: 12092802 · Received June 30, 2021

    Report

    Report Number
    2029214-2021-00795
    Event Type
    Death
    Date Received
    June 30, 2021
    Date of Event
    December 4, 2020
    Report Date
    November 25, 2025
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    QJP
    UDI-DI
    00847536031807
    PMA / PMN Number
    K182097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED A NEW ISCHEMIC STROKE.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED LOCATION OF PROXIMAL FACE OF CLOT 1: LOCATION: CAROTID T HEMISPHERE: RIGHT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENING OF (B)(6) 2021 THE PATIENT HAD A SUDDEN WORSENING DUE TO THE LEVEL OF CONSCIOUSNESS, AND THE PATIENT¿S NIHSS SCORE HAD DROPPED FROM 6 TO 39. A CT SCAN ON (B)(6) 2021 SHOWED A DEFECT IN THE COMMUNICATING SEGMENT (C7) OF THE LEFT ICA THAT EXTENDS TO THE PROXIMAL REGION OF THE HOMOLATERAL A1 AND M1 SEGMENTS, EXTENSIVE MISMATCH AREA IN THE TERRITORY OF BOTH ACAS AND LEFT MCA WITH AN ESTABLISHED LEFT FRONTAL ISCHEMIC AREA (M1 TERRITORY), AND DISSECTION OF EXTRACRANIAL RIGHT INTERNAL CAROTID ARTERY. AN OCCLUSION WAS OBSERVED IN THE LEFT ICA TERRITORY. ON (B)(6) 2020 THE PATIENT PRESENTED WITH SYMPTOMS OF SUDDEN WORSENING WITH TETRAPARESIS, APHASIA, LEFT DOC AND THE REMAINING ARTIFACTUAL EXPLORATION BY LEVEL OF CONSCIOUSNESS (NIHSS 39). A MULTIMODAL CT SCAN WAS PERFORMED ON THIS DATE IN WHICH OCCLUSION WAS OBSERVED IN THE DISTAL SEGMENT OF THE LEFT ICA. A MECHANICAL THROMBECTOMY WAS PERFORMED AND COMPLETE RECANALIZATION WAS ACHIEVED. THEIR NIHSS SCORE WAS 27 LATER THAT DAY AND CONTINUED TO PRESENT RESPIRATORY DISTRESS REQUIRING OXYGEN THERAPY. AFTER THE PROCEDURE, THE PATIENT SHOWED GRADUAL RESPIRATORY DETERIORATION WITHIN THE CONTEXT OF POSSIBLE BRONCHOASPIRATION NOT RESPONSIVE TO BRONCHODILATOR TREATMENT AND OXYGEN THERAPY, SO IT WAS DECIDED ALONG WITH THE FAMILY TO LIMIT TREATMENT EFFORTS. THE PATIENT SHOWED POOR EVOLUTION AND PASSES AWAY AT (B)(6)2020. THE ROOT CAUSE OF THE PATIENT DEATH WAS ISCHEMIC STROKE, WITH INTERMEDIATE CAUSE OF BRONCHOASPIRATION AND ACUTE RESPIRATORY FAILURE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE 24 HOUR FOLLOW-UP IMAGING CT IMAGING SHOWED INFARCTION IN A NEW VASCULAR TERRITORY. DURING TREATMENT, ONLY ONE PASS WAS MADE, AND THE STROKE ONSET TO REPERFUSION TIME WAS UNKNOWN BUT FINAL PERFUSION WAS (B)(6) 2020 AT 03:09. IT WAS ALSO REPORTED THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF ISCHEMIC STROKE OF THE CAROTID T. THE BASELINE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE WAS 15, AND POST-PROCEDURE NIHSS SCORE WAS 7. THE BASELINE AND POST-PROCEDURE MODIFIED THROMBOLYSIS IN CEREBRAL INFARCTION (MTICI) SCORE WAS 3. THE PATIENT HAD A MEDICAL HISTORY INCLUDING ATRIAL FLUTTER OR ATRIAL FIBRILLATION, DIABETES MELLITUS, HYPERLIPIDEMIA, HYPERTENSION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INITIAL FINDINGS AT 24-HOUR POST PROCEDURE FOLLOW-UP OF ACUTE INFARCTION OF THE DEEP RIGHT MIDDLE CEREBRAL ARTERY (MCA) ALSO SHOWED HYPERDENSE TRANSFORMATION WHICH COULD CORRESPOND WITH CONTRAST RETENTION AND HEMORRHAGIC TRANSFORMATION WITH COMPRESSION OF THE LATERAL VENTRICLE COULD NOT BE RULED OUT. BASED ON THE FINDINGS, INITIATION OF ANTICOAGULATION TREATMENT WAS POSTPONED. FOLLOW-UP COMPUTER TOMOGRAPHY PERFUSION (CTP) WAS DONE ON (B)(6) 2020 AND SHOWED A REDUCTION OF THE HYPERDENSITY WITH LESS COMPRESSION ON THE VENTRICULAR SYSTEM. COMPUTER TOMOGRAPHY ANGIOGRAPHY (CTA) ON (B)(6) 2020 SHOWED RESOLUTION OF THE HYPERDENSITY. HOWEVER, THE PATIENT DIED ON (B)(6) 2020. THE EVENTS WERE DETERMINED TO BE CAUSED BY THE DISEASE UNDER STUDY. SITE INVESTIGATION DETERMINED THE EVENTS WERE NOT RELATED TO THE PROCEDURE NOR TO EITHER MEDTRONIC DEVICE USED. HOWEVER, MEDTRONIC ASSESSMENT OF THE EVENT OF INFARCT TO NEW VASCULAR TERRITORY DETERMINED THE EVENT WAS POSSIBLY RELATED TO THE PROCEDURE AND THE REACT AND SOLITAIRE DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990651 REACT CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MICRO THERAPEUTICS, INC. DBA EV3 REACT-71 A980852 00847536031807

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention| D