BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRAGG-MCNAMARA

    MDR report key: 24818124 · Received April 8, 2026

    Report

    Report Number
    2029214-2026-00629
    Event Type
    Death
    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. SERIOUS INJURIES NOT RESULTING IN DEATH THAT WERE REPORTED IN THE ARTICLE WILL BE SENT OUT SEPARATELY. 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.

    Additional Manufacturer Narrative · 0

    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. 1 PATIENT WHO UNDERWENT CDT WAS REPORTED TO HAVE AN OUTCOME OF POST-OPERATIVE MORTALITY. THE PATIENT HAD INCOMPLETE OR UNSUCCESSFUL CDT AND UNDERWENT MULTIPLE UNSUCCESSFUL BAILOUT ATTEMPTS AND ULTIMATELY DIED AFTER >7 DAYS. THERE WAS ANOTHER PATIENT DEATH REPORTED IN THE CDT GROUP DUE TO ABDOMINAL HEMATOMAS AND MAJOR BLEEDING WHICH WAS ATTRIBUTED TO THROMBOLYTIC/ANTIPLATELET TREATMENT AND NOT ASSOCIATED DIRECTLY WITH THE PROCEDURE OR DEVICES AND, THEREFORE, IS NOT CONSIDERED A COMPLAINT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT INARI WAS THE MANUFACTURER OF THE DEVICES AND NOT MEDTRONIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876747 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 Death