BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XIENCE PRO¿ S

    MDR report key: 22842963 · Received August 19, 2025

    Report

    Report Number
    2024168-2025-08711
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 19, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648295560
    PMA / PMN Number
    P110019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. FACTORS THAT COULD CONTRIBUTE TO MATERIAL DEFORMATION INCLUDE, BUT ARE NOT LIMITED TO, INADVERTENT MISHANDLING DURING SHEATH/STYLET REMOVAL, PREPARATION, DURING USE OF THE DEVICE, OR INTERACTION WITH ANATOMY OR ACCESSORY DEVICES. DEVICE DAMAGED BY ANOTHER DEVICE MAY BE ATTRIBUTED TO SEVERAL FACTORS INCLUDING, BUT ARE NOT LIMITED TO, LESION INADEQUATELY PREDILATED, LESION SELECTION (NOT TREATING THE DISTAL LESION FIRST), INTERACTION BETWEEN ACCESSORY DEVICES OR PREVIOUSLY IMPLANTED STENTS. IN THIS CASE, IT IS POSSIBLE THAT ANOTHER DEVICE INTERACTED WITH THE PREVIOUSLY IMPLANTED XIENCE PROS DURING ADVANCEMENT AND RETRACTION, CAUSING THE REPORTED MATERIAL DEFORMATION AND DEVICE DAMAGED BY ANOTHER DEVICE; HOWEVER, THIS CANNOT BE CONFIRMED. BASED ON THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A DE NOVO LESION IN THE LEFT CORONARY ARTERY (LCA) WITH 95% STENOSIS, MODERATE CALCIFICATION, AND MODERATE TORTUOSITY. A 3.5X28MM XIENCE STENT (4091041) WAS IMPLANTED ON (B)(6) 2025 WITHOUT ISSUE. ON (B)(6) 2025, PRE-DILATION WAS PERFORMED USING A 2.0X20MM TREK BALLOON INFLATED TO 16 ATMOSPHERES (ATMS). HOWEVER, THE 2.5X28 XIENCE STENT (LOT 4071741) AND 2.0X15MM XIENCE PROS SDS (4041941) FAILED TO CROSS DUE TO ANATOMICAL CHALLENGES. THEN A 2.25X28MM XIENCE PROS STENT DELIVERY SYSTEM (SDS) (4071741) WAS ATTEMPTED TO BE ADVANCED BUT COULD NOT PASS THROUGH THE DISTAL LESION OF THE CIRCUMFLEX (CX) ARTERY. UPON WITHDRAWAL, THE STENT BECAME ENTANGLED WITH THE FIRST IMPLANTED STENT (4091041) AT THE OSTIUM OF THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. SEVERAL MANEUVERS WERE ATTEMPTED, BUT THE STENT (4071741) COULD NOT BE FULLY RETRIEVED. USING A SNARE-TYPE CATHETER, PART OF THE STENT (4071741) WAS PARTIALLY REMOVED VIA RADIAL ACCESS, WHILE ANOTHER PART MIGRATED THROUGH THE DESCENDING AORTA AND BECAME LODGED IN THE LEFT ILIAC ARTERY. THE PATIENT BEGAN EXPERIENCING ANGINA AND A CONTROL ANGIOGRAPHY REVEALED A THROMBOTIC OCCLUSION OF THE LAD ARTERY. MYOCARDIAL INFARCTION WAS DIAGNOSED. MULTIPLE ATTEMPTS WERE MADE TO PASS A NON-ABBOTT GUIDEWIRE THROUGH THE OSTIUM OF THE LAD ARTERY, BUT WAS UNSUCCESSFUL, LIKELY DUE TO DEFORMATION OF THE FIRST IMPLANTED STENT (4091041). THE PATIENT THEN EXPERIENCED PULSELESS ELECTRICAL ACTIVITY ,CARDIAC ARREST, PROMPTING EXTERNAL CARDIAC MASSAGE, ADMINISTRATION OF UP TO 15 MG OF IV EPINEPHRINE, AND OROTRACHEAL INTUBATION WITH VENTILATION USING AN AMBU BAG. AT ONE POINT, THE PATIENT DEVELOPED VENTRICULAR FIBRILLATION, AND UNSYNCHRONIZED CARDIOVERSION WITH 200 J WAS PERFORMED, RESTORING A SUPRAVENTRICULAR RHYTHM. ADDITIONALLY, 1 G OF IV LIDOCAINE WAS ADMINISTERED. ANOTHER ATTEMPT WAS MADE TO PASS AN UNSPECIFIED GUIDEWIRE INTO THE LAD ARTERY, BUT IT WAS UNSUCCESSFUL. TO IMPROVE HEMODYNAMICS AND REDUCE THE ISCHEMIC BURDEN A DECISION WAS MADE TO TREAT THE CX ARTERY AS THE PATIENT REMAINED IN CARDIAC ARREST, REFRACTORY TO TREATMENT. AN UNSPECIFIED GUIDEWIRE WAS ADVANCED TO THE DISTAL SEGMENT OF THE CX ARTERY, AND THE LESION WAS PREDILATED. A CORONARY RUPTURE WITH CONTRAST EXTRAVASATION INTO THE PERICARDIUM WAS OBSERVED AND AN UNSPECIFIED BALLOON WAS LEFT INFLATED AT THE SITE TO STOP THE BLEEDING. A TRANSTHORACIC DOPPLER ECHOCARDIOGRAM WAS THEN PERFORMED, REVEALING A MILD PERICARDIAL EFFUSION LOCALIZED IN THE LATERAL REGION, WITHOUT INVOLVEMENT OF THE RIGHT HEART CHAMBERS. RESUSCITATION MANEUVERS WERE CONTINUED FOR 40 MINUTES, BUT SPONTANEOUS HEMODYNAMIC RECOVERY WAS NOT ACHIEVED. THE PATIENT DIED THE SAME DAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1483909 XIENCE PRO¿ S CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR 1508350-28 4091041 08717648295560

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Unknown ASAHI SION BLUE 0.01| EBU 3.5 6 F GUIDE CATHETER