BEUDAMED
    FDA Adverse Event Injury Summary report: N

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    MDR report key: 21146929 · Received January 14, 2025

    Report

    Report Number
    1220452-2025-00003
    Event Type
    Injury
    Date Received
    January 14, 2025
    Date of Event
    August 12, 2023
    Report Date
    February 13, 2025
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K040869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SUKHDEEP BHOGAL, AKHIL KALLUR, ILAN MERDLER, ITSIK BEN-DOR, ADITYA DEVINENI, HAYDER D HASHIM, NELSON L BERNARDO, TOBY ROGERS, JASON P WERMERS, LOWELL F SATLER, HECTOR M GARCIA-GARCIA, RON WAKSMAN. ¿ASPIRATION THROMBECTOMY WITH AND WITHOUT CANGRELOR DURING PERCUTANEOUS CORONARY INTERVENTION¿. AMERICAN JOURNAL OF CARDIOLOGY, NO. 209, 2023, DOI: 10.1016/J.AMJCARD.2023.08.070. PMID: 37871514. PAGES: 89-91. A2: AVERAGE AGE A3: MAJORITY GENDER B3: DATE OF PUBLICATION EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT. PATIENT DEATHS WERE ALSO INCLUDED IN THE RESULTS OF THE JOURNAL ARTICLE, HOWEVER NO CAUSAL LINK SUGGESTING THAT THE MEDTRONIC DEVICES USED IN THE PATIENT COHORT MAY HAVE CAUSED OR CONTRIBUTED TO THE DEATHS WAS PROVIDED. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. 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

    ADDITIONAL INFORMATION: ANNEX D CODE. 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

    A JOURNAL ARTICLE WAS SUBMITTED FOR REVIEW TITLED ¿ASPIRATION THROMBECTOMY WITH AND WITHOUT CANGRELOR DURING PERCUTANEOUS CORONARY INTERVENTION¿. THE AIM OF THIS RETROSPECTIVE, SINGLE-CENTER STUDY WAS TO ASSESS THE USE OF INTRAVENOUS CANGRELOR DURING PERCUTANEOUS CORONARY INTERVENTION (PCI), WITH THROMBECTOMY. FROM NOVEMBER 2013 TO DECEMBER 2021, A TOTAL OF 588 PATIENTS WITH ASPIRATION THROMBECTOMY WERE IDENTIFIED, OF WHOM 202 RECEIVED CANGRELOR AND 386 DID NOT (CONTROL GROUP). THE MEDTRONIC EXPORT ASPIRATION CATHETER WAS AMONG MULTIPLE OTHER NON-MEDTRONIC ASPIRATION THROMBECTOMY CATHETERS USED. MEDTRONIC SOLITAIRE DEVICES WERE ALSO USED. RESULTS FOUND THERE WAS NO DIFFERENCE IN IN-HOSPITAL ALL-CAUSE MORTALITY BETWEEN THE GROUPS (1.5% VS 1.1%). THE USE OF CANGRELOR WAS ASSOCIATED WITH A LOWER RATE OF HEMATOMA (0% VS 2.6%), BUT THE RATES OF BLOOD TRANSFUSION (4% VS 1.8%) REMAINED SIMILAR BETWEEN THE GROUPS. ISCHEMIC END POINTS, INCLUDING STENT THROMBOSIS (0.5% VS 1.3) AND STROKE (3.5% VS 2.8%), WERE COMPARABLE BETWEEN THE GROUPS. THROMBOLYSIS IN MYOCARDIAL INFARCTION (TIMI)-3 FLOW AFTER PCI WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE GROUPS (92.1% VS 93.5%).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485728 EXPORT CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Other