BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPORT UNKNOWN

    MDR report key: 23552643 · Received November 14, 2025

    Report

    Report Number
    1220452-2025-00029
    Event Type
    Injury
    Date Received
    November 14, 2025
    Date of Event
    May 28, 2025
    Report Date
    December 12, 2025
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K040869
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AHMED MOHAMED SHAWKY ASFOUR, MOHAMED OSMAN IBRAHIM, KARIM SALEM MASHHOUR, ASHRAF AHMED ABDEL MEGEED, AKRAM MOHAMED ABD EL-BARY "EFFECT OF INTRACORONARY TIROFIBAN THROUGH GUIDING CATHETER COMPARED WITH INTRACORONARY TIROFIBAN THROUGH ASPIRATION CATHETER ON THE MICROVASCULAR OBSTRUCTION IN PATIENTS WITH STEMI UNDERGOING PCI: A CARDIAC MR STUDY" CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS 2025; 106:1187¿1195 DOI: HTTPS://DOI.ORG/10.1002/CCD.31665 A2: AVERAGE AGE A3: MAJORITY GENDER B3: DATE OF PUBLICATION NO UNIQUE DEVICE IDENTIFIER (LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. 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 "EFFECT OF INTRACORONARY TIROFIBAN THROUGH GUIDING CATHETER COMPARED WITH INTRACORONARY TIROFIBAN THROUGH ASPIRATION CATHETER ON THE MICROVASCULAR OBSTRUCTION IN PATIENTS WITH STEMI UNDERGOING PCI: A CARDIAC MR STUDY". THIS STUDY AIMED TO ASSESS THE EFFECTIVENESS AND SAFETY OF TWO DIFFERENT TIROFIBAN DELIVERY METHODS IN IMPROVING MYOCARDIAL PERFUSION AND CLINICAL OUTCOMES IN ST-ELEVATION MYOCARDIAL INFARCTION (STEMI) PATIENTS WITH MICROVASCULAR OBSTRUCTION (MVO) UNDERGOING REPERFUSION THERAPY. THE STUDY COMPARED INTRACORONARY TIROFIBAN DELIVERY VIA GUIDING CATHETER VERSUS ASPIRATION CATHETER. A TOTAL OF 118 PATIENTS MET INCLUSION CRITERIA AND WERE INCLUDED IN THIS STUDY. THE STUDY WAS CONDUCTED FOR 2 YEARS STARTING FROM SEPTEMBER 2021 TO SEPTEMBER 2023. THE 118 PATIENTS WERE RANDOMIZED INTO TWO GROUPS: GROUP A (N = 56) RECEIVED TIROFIBAN VIA GUIDING CATHETER, AND GROUP B (N = 62) VIA ASPIRATION CATHETER. LESIONS TREATED DURING THE PROCEDURE INCLUDED THE LEFT ANTERIOR DESCENDING ARTERY (LAD), LEFT CIRCUMFLEX ARTERY (LCX), OBTUSE MARGINAL (OM), POSTERIOR LATERAL ARTERY (PL) AND THE RIGHT CORONARY ARTERY (RCA). ASPIRATION THROMBECTOMY WAS PERFORMED IN ALL PATIENTS USING A MEDTRONIC 6F EXPORT CATHETER. THE PROTOCOL SPECIFIED ACTIVELY ASPIRATING WHENEVER CROSSING THE LESION OR WITHDRAWING THE CATHETER, MAKING SEVERAL PASSES UNTIL NO FURTHER THROMBUS OR DEBRIS WAS RETRIEVED. TO ENSURE HIGH INTRA-THROMBUS DRUG CONCENTRATIONS, TIROFIBAN¿LOADING DOSE 10 MCG/KG THROUGH ASPIRATION DEVICE AFTER FLUSHING OF THE ASPIRATION DEVICE WELL OR GUIDING CATHETER¿WERE ADMINISTERED WHEN THROMBUS BURDEN IS INDICATED FOLLOWING CORONARY ANGIOGRAPHY AND PCI WAS PERFORMED USING STANDARD TECHNIQUES, WITH DRUG-ELUTING STENTS IMPLANTATION. PRIMARY OUTCOMES INCLUDED CARDIAC MAGNETIC RESONANCE (CMR) MEASUREMENTS INCLUDING MYOCARDIAL SALVAGE INDEX, FINAL INFARCT SIZE, PREVALENCE AND EXTENT OF MVO%, AND LEFT VENTRICULAR EJECTION FRACTION (LVEF) AND AREA AT RISK (AAR). SECONDARY OUTCOMES INCLUDED MAJOR ADVERSE CARDIAC EVENTS (MACE) AND BLEEDING. CLINICAL FOLLOW-UP FOR THE OCCURRENCE OF MACE WAS PERFORMED IN HOSPITAL AND WITHIN MEAN PERIOD 4 MONTHS (6-9 MONTHS). PATIENTS RECEIVING TIROFIBAN VIA ASPIRATION CATHETER HAD A SIGNIFICANTLY LOWER MEDIAN MVO AND A HIGHER MYOCARDIAL SALVAGE INDEX COMPARED TO THE OTHER GROUP. NO SIGNIFICANT DIFFERENCE WAS REPORTED BETWEEN BOTH GROUPS REGARDING MACE. MACE DURING THE 3-MONTH FOLLOW-UP WAS REPORTED IN 3 PATIENTS IN THE ASPIRATION CATHETER GROUP AND 6 PATIENTS IN THE GUIDE CATHETER GROUP. MINOR BLEEDING OCCURRED IN 6 PATIENTS IN THE ASPIRATION CATHETER GROUP AND 6 PATIENTS IN THE GUIDE CATHETER GROUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1977539 EXPORT UNKNOWN CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Other