BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMERGE

    MDR report key: 21449715 · Received February 24, 2025

    Report

    Report Number
    2124215-2025-11060
    Event Type
    Death
    Date Received
    February 24, 2025
    Date of Event
    January 24, 2025
    Report Date
    February 24, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    UDI-DI
    08714729806257
    PMA / PMN Number
    K113220,
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 PMA/510(K): K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PERORATION AND DEATH OCCURRED. ON (B)(6) 2025, THE PATIENT PRESENTED WITH STABLE ANGINA. THE SAME DAY THE PATIENT UNDERWENT PERCUTANEOUS CORONARY INTERVENTION USING CUTTING BALLOON ANGIOPLASTY IN THE PROXIMAL LEFT ANTERIOR DESCENDING (LAD). THE LESION WAS PREDILATED WITH A 15 MM X 3.00 MM WOLVERINE CORONARY CUTTING BALLOON AT THE LAD. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED, AND ADDITIONAL DILATATION WAS PERFORMED WITH A 3.50 MM X 15 MM EMERGE BALLOON AND A 4.00 MM X 8 MM EMERGE BALLOON. AN ELLIS CLASS 3 PERFORATION IN THE PROXIMAL LAD OCCURRED WHICH WAS CONSIDERED TO HAVE BEEN CAUSED BY THE 3.50 X 15MM EMERGE BALLOON. THE PERFORATION WAS COVERED INITIALLY WITH A 4.00 X 20 MM NON-BOSTON SCIENTIFIC (NON-BSC) STENT AND PERICARDIOCENTESIS PERFORMED. A 3.00 X 20 MM NON-BSC STENT WAS IMPLANTED DISTAL TO THE INITIAL COVER STENT IN VIEW OF PERSISTENT EXTRAVASATION. CARDIOPULMONARY RESUSCITATION (CPR) WAS STARTED DUE TO PROFOUND HYPOTENSION. THE PATIENT WAS INTUBATED, AND VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA ECMO) WAS INSERTED. THE LEFT MAIN (LM) WAS RE-ENGAGED VIA THE LEFT FEMORAL ARTERY (LFA) USING AN 8FR NON-BSC GUIDING CATHETER. IT WAS SEEN THAT THE PERFORATION WAS SEALED, AND THE FIRST DIAGONAL WAS LOST BUT THERE WAS SATISFACTORY IVUS AND ANGIOGRAPHIC RESULT. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) SHOWED RESTRICTION AND A CALCIFIED AORTIC VALVE. BALLOON VALVULOPLASTY WAS PERFORMED WITH A 20 MM NON-BSC BALLOON. A REPERFUSION SHEATH 6FR WAS INSERTED TO THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PATIENT WAS ON ECMO WITH LOW FLOWS AND CHUGGING. THE PERICARDIAL DRAIN HAD BEEN REMOVED. THERE WAS CONCERN FOR RIGHT-SIDED CREPITUS AND A CHEST X RAY WAS OBTAINED. THE PATIENT HAD WORSENING PRESSOR REQUIREMENTS STATUS POST 7 LITERS OF INTRAVENOUS FLUID PROMPTING TRANSFUSION OF MULTIPLE BLOOD PRODUCTS. THE PATIENT SUFFERED A CARDIAC ARREST AND RETURN OF SPONTANEOUS CIRCULATION (ROSC) WAS ACHIEVED AFTER 1 ROUND OF CPR, EPI AND BICARB. BEDSIDE CARDIAC ULTRASOUND SHOWED MODERATE PERICARDIAL EFFUSION. THE NEXT DAY, THE PATIENT CONDITION WAS FURTHER COMPLICATED BY ECMO CHUGGING AND ELEVATED CENTRAL VENOUS PRESSURE (CVP). ADDITIONALLY, THE PATIENT EXPERIENCED AN ACUTE ISCHEMIC STROKE OF THE LEFT OCCIPITAL AND CEREBELLAR LOBES WITHOUT THROMBOLYSIS OR THROMBECTOMY, AND DEVELOPED THROMBOCYTOPENIA, LEADING TO THE DISCONTINUATION OF HEPARIN. ON (B)(6) 2025, THE PATIENT SUBSEQUENTLY UNDERWENT REPEAT PERICARDIAL DRAINAGE WITH PIGTAIL PLACEMENT AND SWAN GANZ INSERTION IN CATHETERIZATION LAB. ON (B)(6) 2025, THE PATIENT NOTED TO HAVE WORSENING PRESSOR REQUIREMENTS, WORSENING LACTATE, WORSENING RENAL FUNCTION, AND DEVELOPED SUSTAINED VENTRICULAR TACHYCARDIA. THE PATIENT WAS STARTED ON AMIODARONE. THE PATIENT WAS WEANED OFF SEDATION WITH NO NEUROLOGIC RESPONSE NOTED OVER COURSE OF 24 HOURS. ON (B)(6) 2025, THE PATIENT WAS NOTED TO BE ASYSTOLE ON MONITOR. THE ECMO CIRCUIT WAS CLAMPED, AND THE VENTILATOR STOPPED. THE SUBJECT WAS PRONOUNCED AS DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612290 EMERGE CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918915350 0034299988 08714729806257

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Death