BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRAGG-MCNAMARA

    MDR report key: 11737100 · Received April 28, 2021

    Report

    Report Number
    2029214-2021-00496
    Event Type
    Death
    Date Received
    April 28, 2021
    Date of Event
    April 1, 2020
    Report Date
    April 28, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K940634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE LITERATURE ARTICLE WHICH CONTAINED THE REPORTED EVENT(S) WAS OMITTED FROM THE INITIAL REPORT AND HAS BEEN ADDED IN ATTACHMENTS TO THIS REPORT. A2. PATIENT AGE IS REPRESENTATIVE OF THE MEAN AGE OF ALL PATIENTS INCLUDED IN THE STUDY. A3. PATIENT SEX IS REPRESENTATIVE OF THE MAJORITY OF PATIENTS INCLUDED IN THE STUDY. 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.

    Description of Event or Problem · 0

    VAKHITOV, D., HAKOVIRTA, H., SAARINEN, E., OKSALA, N., <(>&<)> SUOMINEN, V. (2020). PROGNOSTIC RISK FACTORS FOR RECURRENT ACUTE LOWER LIMB ISCHEMIA IN PATIENTS TREATED WITH INTRA-ARTERIAL THROMBOLYSIS. JOURNAL OF VASCULAR SURGERY, 71(4), 1268¿1275. HTTPS://DOI.ORG /10.1016/J.JVS.2019.07.061 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND THAT THE ARTICLE REVIEWED PATIENTS WERE TREATED FOR ACUTE LOWER LIMB ISCHEMIC WITH CATHETER-DIRECTED THROMBOLYSIS (CDT) BETWEEN MARCH 2002 AND DECEMBER 2015. 303 PATIENTS WITH A MEAN AGE OF 71 WERE INCLUDED IN THE STUDY. 52.5% OF THE PATIENTS WERE MALE. PATIENTS WERE TREATED UNDER LOCAL ANESTHESIA USING EITHER A CONTRALATERAL APPROACH OR VIA THE IPSILATERAL FEMORAL ARTERY. A MULTI-HOLE CRAGG-MCNAMARA INFUSION CATHETER WAS PLACED WITHIN THE THROMBUS AND RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR WAS ADMINISTERED AS AN INITIAL 4MG BOLUS. THE TREATMENT CONTINUED WITH AN INFUSION OF 0.5MG/HOUR FOR A MAXIMUM OF 48 HOURS, WITH CONTROL ANGIOGRAMS TAKEN EVERY 24 HOURS (+/- 2 HOURS). LYTIC THERAPY WAS CONSIDERED COMPLETE WITH LYSIS OF THE THROMBUS AND FLOW RESTORATION. IN SOME CASES DUPLEX ULTRASOUND (US) AND PLAIN RADIOGRAPHY WERE USED FOR THE DIFFERENTIAL DIAGNOSIS OF RESIDUAL THROMBUS DURING CDT. PATIENTS REMAINED IN EITHER THE INTENSIVE CARE UNIT (ICU) OR 24-HOUR OBSERVATION WARD UNTIL THE THROMBOLYTIC TREATMENT WAS COMPLETED. HEPARIN WAS NOT ADMINISTERED THROUGH THE SHEATH, BUT RATHER SUBCUTANEOUSLY TWICE DAILY. TREATMENT DURATION WITH LOW-MOLECULAR-WEIGHT HEPARIN RANGED FROM SEVERAL DAYS TO A MAXIMUM OF SEVERAL WEEKS DEPENDING ON THE PATIENT¿S LEVEL OF PHYSICAL ACTIVITY AND THE NEED FOR CONTINUOUS ORAL ANTICOAGULANT THERAPY WHICH VARIED. THE PATIENTS WERE OBSERVED FOR VARYING PERIODS. MOST PATIENTS UNDERWENT THE FIRST ROUTINE FOLLOW-UP VISIT AT 1 MONTH POST-PROCEDURE. SUBSEQUENT FOLLOW-UP VISITS WERE SCHEDULED AT DIFFERENT TIME INTERVALS UNTIL THE PATIENTS DID NOT REQUIRE ADDITIONAL MANIPULATIONS AND THERE WERE NO SYMPTOMS AND SIGNS OF CRITICAL LIMB ISCHEMIA. IN FURTHER POST-THROMBOLYTIC FOLLOW-UP, NATIVE ARTERIAL AND PROXIMAL BYPASS GRAFT PATIENTS (ABOVE-KNEE) UNDERWENT PHYSICAL EXAMINATIONS IN THEIR REGIONAL PRIMARY HEALTH CARE CENTERS ONCE A YEAR OR MORE FREQUENTLY. ULTRASOUND AND ANKLE-BRACHIAL INDEX (ABI) MEASUREMENTS WERE PERFORMED ON SYMPTOMATIC PATIENTS. BELOW-KNEE BYPASS GRAFT PATIENTS UNDERWENT HOSPITAL FOLLOW-UP BIANNUALLY. THE VISITS ROUTINELY INCLUDED PHYSICAL EXAMINATIONS, ABI, TOE PRESSURE MEASUREMENTS, AND ULTRASOUND. ADDITIONAL ELECTIVE, URGENT, AND EMERGENCY FOLLOW-UP VISITS AND ADMISSIONS WERE ARRANGED ON THE BASIS OF THE CLINICAL SITUATION, AND THE NEED FOR ANGIOGRAPHY WAS ASSESSED. THE ARTICLE NOTED ADDITIONAL TREATMENT NECESSARY IN A MAJORITY OF CASES AND CONCLUDED THAT APPROPRIATE POST-THROMBOLYTIC ANTIPLATELET OR ANTICOAGULANT TREATMENT AFTER NATIVE ARTERIAL EVENTS IS OF GREAT IMPORTANCE, BUT ADDITIONAL DATA WAS NEEDED TO IMPROVE TREATMENT ALGORITHMS. CDT AS A SINGLE TREATMENT WAS EFFECTIVE IN 100 CASES. ONE PATIENT UNDERWENT PREPLANNED ADJUNCTIVE ATHERECTOMY WITH THROMBECTOMY. NO DEVICE MALFUNCTIONS WERE REPORTED. FOUR PATIENTS (1.3%) DEVELOPED INTRACRANIAL BLEEDING, AND TWO OF THEM DIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    VAKHITOV, D., HAKOVIRTA, H., SAARINEN, E., OKSALA, N., <(>&<)> SUOMINEN, V. (2020). PROGNOSTIC RISK FACTORS FOR RECURRENT ACUTE LOWER LIMB ISCHEMIA IN PATIENTS TREATED WITH INTRA-ARTERIAL THROMBOLYSIS. JOURNAL OF VASCULAR SURGERY, 71(4), 1268¿1275. HTTPS://DOI.ORG /10.1016/J.JVS.2019.07.061 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND THAT THE ARTICLE REVIEWED PATIENTS WERE TREATED FOR ACUTE LOWER LIMB ISCHEMIC WITH CATHETER-DIRECTED THROMBOLYSIS (CDT) BETWEEN MARCH 2002 AND DECEMBER 2015. 303 PATIENTS WITH A MEAN AGE OF 71 WERE INCLUDED IN THE STUDY. 52.5% OF THE PATIENTS WERE MALE. PATIENTS WERE TREATED UNDER LOCAL ANESTHESIA USING EITHER A CONTRALATERAL APPROACH OR VIA THE IPSILATERAL FEMORAL ARTERY. A MULTI-HOLE CRAGG-MCNAMARA INFUSION CATHETER WAS PLACED WITHIN THE THROMBUS AND RECOMBINANT TISSUE PLASMINOGEN ACTIVATOR WAS ADMINISTERED AS AN INITIAL 4MG BOLUS. THE TREATMENT CONTINUED WITH AN INFUSION OF 0.5MG/HOUR FOR A MAXIMUM OF 48 HOURS, WITH CONTROL ANGIOGRAMS TAKEN EVERY 24 HOURS (+/- 2 HOURS). LYTIC THERAPY WAS CONSIDERED COMPLETE WITH LYSIS OF THE THROMBUS AND FLOW RESTORATION. IN SOME CASES DUPLEX ULTRASOUND (US) AND PLAIN RADIOGRAPHY WERE USED FOR THE DIFFERENTIAL DIAGNOSIS OF RESIDUAL THROMBUS DURING CDT. PATIENTS REMAINED IN EITHER THE INTENSIVE CARE UNIT (ICU) OR 24-HOUR OBSERVATION WARD UNTIL THE THROMBOLYTIC TREATMENT WAS COMPLETED. HEPARIN WAS NOT ADMINISTERED THROUGH THE SHEATH, BUT RATHER SUBCUTANEOUSLY TWICE DAILY. TREATMENT DURATION WITH LOW-MOLECULAR-WEIGHT HEPARIN RANGED FROM SEVERAL DAYS TO A MAXIMUM OF SEVERAL WEEKS DEPENDING ON THE PATIENT¿S LEVEL OF PHYSICAL ACTIVITY AND THE NEED FOR CONTINUOUS ORAL ANTICOAGULANT THERAPY WHICH VARIED. THE PATIENTS WERE OBSERVED FOR VARYING PERIODS. MOST PATIENTS UNDERWENT THE FIRST ROUTINE FOLLOW-UP VISIT AT 1 MONTH POST-PROCEDURE. SUBSEQUENT FOLLOW-UP VISITS WERE SCHEDULED AT DIFFERENT TIME INTERVALS UNTIL THE PATIENTS DID NOT REQUIRE ADDITIONAL MANIPULATIONS AND THERE WERE NO SYMPTOMS AND SIGNS OF CRITICAL LIMB ISCHEMIA. IN FURTHER POST-THROMBOLYTIC FOLLOW-UP, NATIVE ARTERIAL AND PROXIMAL BYPASS GRAFT PATIENTS (ABOVE-KNEE) UNDERWENT PHYSICAL EXAMINATIONS IN THEIR REGIONAL PRIMARY HEALTH CARE CENTERS ONCE A YEAR OR MORE FREQUENTLY. ULTRASOUND AND ANKLE-BRACHIAL INDEX (ABI) MEASUREMENTS WERE PERFORMED ON SYMPTOMATIC PATIENTS. BELOW-KNEE BYPASS GRAFT PATIENTS UNDERWENT HOSPITAL FOLLOW-UP BIANNUALLY. THE VISITS ROUTINELY INCLUDED PHYSICAL EXAMINATIONS, ABI, TOE PRESSURE MEASUREMENTS, AND ULTRASOUND. ADDITIONAL ELECTIVE, URGENT, AND EMERGENCY FOLLOW-UP VISITS AND ADMISSIONS WERE ARRANGED ON THE BASIS OF THE CLINICAL SITUATION, AND THE NEED FOR ANGIOGRAPHY WAS ASSESSED. THE ARTICLE NOTED ADDITIONAL TREATMENT NECESSARY IN A MAJORITY OF CASES AND CONCLUDED THAT APPROPRIATE POST-THROMBOLYTIC ANTIPLATELET OR ANTICOAGULANT TREATMENT AFTER NATIVE ARTERIAL EVENTS IS OF GREAT IMPORTANCE, BUT ADDITIONAL DATA WAS NEEDED TO IMPROVE TREATMENT ALGORITHMS. CDT AS A SINGLE TREATMENT WAS EFFECTIVE IN 100 CASES. ONE PATIENT UNDERWENT PREPLANNED ADJUNCTIVE ATHERECTOMY WITH THROMBECTOMY. NO DEVICE MALFUNCTIONS WERE REPORTED. FOUR PATIENTS (1.3%) DEVELOPED INTRACRANIAL BLEEDING, AND TWO OF THEM DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634012 CRAGG-MCNAMARA CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CRAGG-MC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death