BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRAGG-MCNAMARA

    MDR report key: 14265993 · Received May 3, 2022

    Report

    Report Number
    2029214-2022-00749
    Event Type
    Injury
    Date Received
    May 3, 2022
    Date of Event
    January 1, 2019
    Report Date
    May 1, 2022
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RAO, G., XU, H., WANG, J. J., GALMER, A., GIRI, J., JAFF, M. R., KOLLURI, R., LAU, J. F., SELIM, S., WEINBERG, I., <(>&<)>AMP; WEINBERG, M. D. (2019). ULTRASOUND-ASSISTED VERSUS CONVENTIONAL CATHETER-DIRECTED THROMBOLYSIS FOR ACUTE PULMONARY EMBOLISM: A MULTICENTER COMPARISON OF PATIENT-CENTERED OUTCOMES. VASCULAR MEDICINE, 24(3), 241¿247. HTTPS://DOI.ORG/10.1177/1358863X19838334. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    RAO, G., XU, H., WANG, J. J., GALMER, A., GIRI, J., JAFF, M. R., KOLLURI, R., LAU, J. F., SELIM, S., WEINBERG, I., & AMP; WEINBERG, M. D. (2019). ULTRASOUND-ASSISTED VERSUS CONVENTIONAL CATHETER-DIRECTED THROMBOLYSIS FOR ACUTE PULMONARY EMBOLISM: A MULTICENTER COMPARISON OF PATIENT-CENTERED OUTCOMES. VASCULAR MEDICINE, 24(3), 241¿247. HTTPS://DOI.ORG/10.1177/1358863X19838334 SUMMARY: BOTH CATHETER-DIRECTED THROMBOLYSIS (CDT) AND ULTRASOUND-ASSISTED THROMBOLYSIS (USAT) ARE NOVEL TREATMENT MODALITIES FOR PATIENTS PRESENTING WITH ACUTE PULMONARY EMBOLISM (PE). THE OBJECTIVE OF THIS STUDY WAS TO COMPARE CLINICAL AND QUALITY-OF-LIFE (QOL) OUTCOMES FOR PATIENTS UNDERGOING EITHER TREATMENT MODALITY. WE RETROSPECTIVELY STUDIED 70 CONSECUTIVE PATIENTS TREATED WITH EITHER CDT OR USAT OVER 3 YEARS AT A MULTICENTER HEALTH SYSTEM. THE PRIMARY CLINICAL EFFICACY ENDPOINT WAS RIGHT VENTRICULAR SYSTOLIC PRESSURE (RVSP) REDUCTION POST-PROCEDURALLY. SAFETY ENDPOINTS WERE MORTALITY AND BLEEDING INCIDENTS BASED ON GLOBAL UTILIZATION OF STREPTOKINASE AND TISSUE PLASMINOGEN ACTIVATOR FOR OCCLUDED ARTERIES (GUSTO) CRITERIA. LONG-TERM QOL WAS ASSESSED USING THE 36-ITEM SHORT-FORM HEALTH SURVEY (SF-36) VIA PHONE INTERVIEW. THIRTY-SEVEN PATIENTS (53%) IN OUR STUDY UNDERWENT USAT AND 33 (47%) PATIENTS WERE TREATED WITH CONVENTIONAL CDT. AMONG ALL PATIENTS STUDIED, 96% HAD ECHOCARDIOGRAPHIC EVIDENCE FOR RIGHT VENTRICULAR STRAIN ON ADMISSION. MEAN RVSP DECREASED BY 18 ± 13 MMHG IN THE USAT GROUP POST-PROCEDURALLY AS COMPARED TO 14 ± 16 MMHG IN THE CDT GROUP, WITHOUT SIGNIFICANT DIFFERENCE BETWEEN GROUPS (P = 0.31). RATES OF MODERATE AND SEVERE BLEEDING WERE LARGELY IDENTICAL BETWEEN USAT AND CDT GROUPS (USAT: 3%; CDT: 0%; P = 0.09). THERE WAS NO DEATH IN EITHER GROUP DURING ADMISSION. AT LONG-TERM FOLLOW-UP, THERE WAS NO SIGNIFICANT DIFFERENCE IN QOL BETWEEN BOTH TREATMENT MODALITIES IN ALL EIGHT FUNCTIONAL DOMAINS OF SF-36. OUR RETROSPECTIVE STUDY DEMONSTRATED USING USAT OVER CONVENTIONAL CDT FOR ACUTE SUBMASSIVE OR MASSIVE PE DID NOT YIELD ADDITIONAL CLINICAL, SAFETY, OR LONG-TERM QOL BENEFIT. IDENTIFIED EVENTS: 1. MEAN RVSP DECREASED BY 18 ± 13 MMHG IN THE USAT GROUP POST-PROCEDURALLY AS COMPARED TO 14 ± 16 MMHG IN THE CDT GROUP, WITHOUT SIGNIFICANT DIFFERENCE BETWEEN GROUPS (P = 0.31). RATES OF MODERATE AND SEVERE BLEEDING WERE LARGELY IDENTICAL BETWEEN USAT AND CDT GROUPS (USAT: 3%; CDT: 0%; P = 0.09). THE ONE GUSTO MODERATE BLEEDING EVENT WAS NOTED IN THE USAT GROUP (3%, P = 0.09) IN THE FORM OF A RETROPERITONEAL BLEED REQUIRING BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1244201 CRAGG-MCNAMARA CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CRAGG-MC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention