BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRAGG-MCNAMARA

    MDR report key: 24818139 · Received April 8, 2026

    Report

    Report Number
    2029214-2026-00630
    Event Type
    Injury
    Date Received
    April 8, 2026
    Date of Event
    February 4, 2025
    Report Date
    April 8, 2026
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    KRA
    PMA / PMN Number
    K940634
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A2. REPORTED PATIENT AGE (61 YEARS) IS THE MEAN AGE FOR ALL PATIENTS INCLUDED IN THE CDT GROUP OF THE STUDY POPULATION. A3. REPORTED PATIENT SEX (MALE) IS REPRESENTATIVELY OF THE MAJORITY (51.4%) OF THE CDT GROUP OF THE STUDY POPULATION. A5B. REPORTED PATIENT RACE (WHITE) IS REPRESENTATIVE OF THE MAJORITY (193/276) OF PATIENTS IN THE CDT GROUP OF THE STUDY POPULATION. B3. REPORTED EVENT DATE IS THE DATE THE ARTICLE WAS PUBLISHED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    JABER, W. A., GONSALVES, C. F., STORTECKY, S., HORR, S., PAPPAS, O., GANDHI, R. T., PEREIRA, K., GIRI, J., KHANDHAR, S. J., AMMAR, K. A., LASORDA, D. M., STEGMAN, B., BUSCH, L., DEXTER, D. J., 2ND, AZENE, E. M., DAGA, N., ELMASRI, F., KUNAVARAPU, C. R., REA, M. E., GIBSON, C. M. (2025). LARGE-BORE MECHANICAL THROMBECTOMY VERSUS CATHETER-DIRECTED THROMBOLYSIS IN THE MANAGEMENT OF INTERMEDIATE-RISK PULMONARY EMBOLISM: PRIMARY RESULTS OF THE PEERLESS RANDOMIZED CONTROLLED TRIAL. CIRCULATION, 151(5), 260¿273. HTTPS://DOI.ORG /10.1161/CIRCULATIONAHA.124.072364 MEDTRONIC REVIEW OF THE LITERATURE ARTICLE FOUND A PROSPECTIVE, MULTICENTER, RANDOMIZED CONTROLLED TRIAL THAT ENROLLED 550 PATIENTS WITH INTERMEDIATE RISK PULMONARY EMBOLISM WITH RIGHT VENTRICULAR DILATATION AND ADDITIONAL CLINICAL RISK FACTORS RANDOMIZED 1:1 TO TREATMENT WITH LARGE-BORE MECHANICAL THROMBECTOMY (LBMT) OR CATHETER-DIRECTED THROMBOLYSIS (CDT). 274 PATIENTS UNDERWENT LBMT AND 276 PATIENTS UNDERWENT CDT. IT WAS NOTED THAT CRAGG-MCNAMARA CATHETERS WERE USED IN SOME CDT PROCEDURES AS WELL AS OTHER MANUFACTURERS' DEVICES. IT WAS NOT SPECIFIED WHAT DEVICE(S) WERE USED IN EACH CASE. NO DEVICE MALFUNCTION WAS REPORTED IN THE ARTICLE. IT WAS NOTED THAT 2 PATIENTS WHO EXPERIENCED MAJOR BLEEDING EPISODES IN THE CDT GROUP WHICH WERE DUE TO THROMBOLYTIC/ANTICOAGULATION TREATMENT AND, THEREFORE, ARE NOT CONSIDERED COMPLAINTS AS THE EVENTS WERE NOT CAUSED BY THE MEDTRONIC DEVICE OR THE PROCEDURE. OTHER SERIOUS ADVERSE EVENTS REPORTED IN THE ARTICLE FOR PATIENT IN THE CDT TREATMENT GROUP INCLUDED: 2 PATIENTS EXPERIENCED CARDIAC ARREST INTRA-OPERATIVELY. 1 PATIENT EXPERIENCED HIGH-GRADE ATRIOVENTRICULAR BLOCK INTRA-OPERATIVELY. 3 PATIENTS EXPERIENCED INTRA-OPERATIVE RESPIRATORY FAILURE. 4 PATIENTS EXPERIENCED INTRA-OPERATIVE HYPOTENSION. 5 PATIENTS REQUIRED BAILOUT THAT WAS ULTIMATELY SUCCESSFUL. OF THESE PATIENTS, 3 REQUIRED BAILOUT DUE TO RESPIRATORY SYMPTOMS AND INADEQUATE THROMBUS RESOLUTION. 1 PATIENT REQUIRED BAILOUT DUE TO RESPIRATORY SYMPTOMS AND HEMODYNAMIC WORSENING. 1 PATIENT REQUIRED BAILOUT SOLELY DUE TO INADEQUATE THROMBUS RESOLUTION. 16 PATIENTS EXPERIENCED BLEEDING WHICH REQUIRED BLOOD TRANSFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877153 CRAGG-MCNAMARA CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. DBA EV3 UNK-NV-CRAGG-MC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention| L