BEUDAMED
    FDA Adverse Event Death Summary report: N

    EMERGE?

    MDR report key: 21309055 · Received February 4, 2025

    Report

    Report Number
    2124215-2025-05048
    Event Type
    Death
    Date Received
    February 4, 2025
    Date of Event
    January 12, 2025
    Report Date
    April 9, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LOX
    PMA / PMN Number
    K113220
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET: K163174. DEVICE EVALUATED BY MFR: THE DEVICE FG EMERGE MR, US 2.50MM X 15MM WAS RETURNED FOR ANALYSIS. VISUAL AND TACTILE INSPECTION IDENTIFIED MULTIPLE KINKS ALONG THE HYPOTUBE SHAFT. VISUAL, TACTILE AND MICROSCOPIC ANALYSIS IDENTIFIED A BREAK IN THE INNER LUMEN AND BALLOON, 22.8CM FROM THE PORT EXCHANGE WITH THE DISTAL SECTION NOT RETURNED. MICROSCOPIC ANALYSIS OF THE BALLOON PROFILE REVEALED A COMPLETE CIRCUMFERENTIAL TEAR 22.8CM FROM THE PORT EXCHANGE WITH THE DISTAL SECTION NOT RETURNED. THE BUMPER TIP SHOWED NO SIGNS OF DISTAL TIP DAMAGE. THE DISTAL MARKERBAND WAS NOT RETURNED, HOWEVER, NO ISSUES WERE NOTED WITH THE PROXIMAL MARKERBAND. NO OTHER DEVICE ISSUES WERE IDENTIFIED DURING RETURNED PRODUCT ANALYSIS.

    Additional Manufacturer Narrative · 0

    G4 - PREMARKET: K163174.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK AND THROMBOSIS OCCURRED, RESULTING IN PATIENT DEATH. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT. CORONARY ANGIOGRAPHY REVEALED THAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS COMPLETELY OCCLUDED FROM THE PROXIMAL SEGMENT, WITH CALCIFICATION VISIBLE DISTAL TO THE OCCLUSION. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED TO TREAT THE LESION DILATED TO 12 ATMOSPHERES FOR 30 SECONDS. WHEN ANOTHER PRE-DILATION NON-BOSTON SCIENTIFIC BALLOON WAS INSERTED, THE PHYSICIAN BELIEVED THAT THE EMERGE BALLOON TIP HAD FRACTURED WITHIN THE GUIDING CATHETER AND THE NON-BSC BALLOON PUSHED THE DEVICE FRAGMENT INTO THE DISTAL LAD. ACUTE THROMBOSIS WAS IDENTIFIED AND NON-BOSTON SCIENTIFIC STENTS WERE IMPLANTED IN THE LAD. THE PATIENT EXPERIENCED CHEST PAIN AND DISCOMFORT. MEDICATION WAS ADMINISTERED AND ANGIOGRAPHY SHOWED GOOD BLOOD FLOW IN THE LAD. THE PATIENT THEN EXPERIENCED A DROP IN BLOOD PRESSURE AND OXYGEN SATURATION. TRACHEAL INTUBATION WAS PERFORMED, AND AN INTRA-AORTIC BALLOON PUMP WAS INSERTED. ADDITIONAL NON-BOSTON SCIENTIFIC STENTS WERE IMPLANTED, AND POST DILATION WAS PERFORMED WITH A QUANTUM BALLOON. REPEAT ANGIOGRAPHY REVEALED GOOD BLOOD FLOW IN THE LAD, HOWEVER, THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP AND HEART RATE DECREASED SIGNIFICANTLY. EXTERNAL CHEST COMPRESSIONS WERE PERFORMED, AND ADDITIONAL MEDICATION WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), WHERE ONE HOUR LATER WAS CONFIRMED DECEASED. IT WAS FURTHER CONFIRMED THAT RE-EXAMINATION ANGIOGRAPHY REVEALED ACUTE THROMBOSIS AFTER BALLOON PRE-TREATMENT WITH THE NON-BSC BALLOON AND THE EMERGE BALLOON IN THE PROXIMAL TO MID-SEGMENT OF THE LAD, WITH A 90% STENOSIS IN THE DISTAL SEGMENT. THEREFORE, AN EMERGE BALLOON WAS INSERTED INTO THE DISTAL SEGMENT LAD FOR PRE-DILATATION PRIOR TO THE NON-BSC STENT IMPLANTATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SHAFT BREAK AND THROMBOSIS OCCURRED, RESULTING IN PATIENT DEATH. THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT. CORONARY ANGIOGRAPHY REVEALED THAT THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WAS COMPLETELY OCCLUDED FROM THE PROXIMAL SEGMENT, WITH CALCIFICATION VISIBLE DISTAL TO THE OCCLUSION. RE-EXAMINATION ANGIOGRAPHY REVEALED A THROMBUS IN THE PROXIMAL TO MID-SEGMENT OF THE ANTERIOR DESCENDING ARTERY, WITH A 90% STENOSIS IN THE DISTAL SEGMENT. A 2.50MM X 15MM EMERGE BALLOON CATHETER WAS ADVANCED TO TREAT THE LESION DILATED TO 12 ATMOSPHERES FOR 30 SECONDS. WHEN ANOTHER PRE-DILATION NON-BOSTON SCIENTIFIC BALLOON WAS INSERTED, THE PHYSICIAN BELIEVED THAT THE EMERGE BALLOON TIP HAD FRACTURED WITHIN THE GUIDING CATHETER AND THE NON-BSC BALLOON PUSHED THE DEVICE FRAGMENT INTO THE DISTAL LAD. ACUTE THROMBOSIS WAS IDENTIFIED, AND NON-BOSTON SCIENTIFIC STENTS WERE IMPLANTED IN THE LAD. THE PATIENT EXPERIENCED CHEST PAIN AND DISCOMFORT. MEDICATION WAS ADMINISTERED AND ANGIOGRAPHY SHOWED GOOD BLOOD FLOW IN THE LAD. THE PATIENT THEN EXPERIENCED A DROP IN BLOOD PRESSURE AND OXYGEN SATURATION. TRACHEAL INTUBATION WAS PERFORMED, AND AN INTRA-AORTIC BALLOON PUMP WAS INSERTED. ADDITIONAL NON-BOSTON SCIENTIFIC STENTS WERE IMPLANTED, AND POST DILATION WAS PERFORMED WITH A QUANTUM BALLOON. REPEAT ANGIOGRAPHY REVEALED GOOD BLOOD FLOW IN THE LAD, HOWEVER, THE PATIENT'S BLOOD PRESSURE CONTINUED TO DROP AND HEART RATE DECREASED SIGNIFICANTLY. EXTERNAL CHEST COMPRESSIONS WERE PERFORMED, AND ADDITIONAL MEDICATION WAS ADMINISTERED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), WHERE ONE HOUR LATER WAS CONFIRMED DECEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1060889 EMERGE? CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC CORPORATION H7493918915250 0034297523

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Unknown Other| R| D