BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE PRO¿ S

    MDR report key: 22842776 · Received August 19, 2025

    Report

    Report Number
    2024168-2025-08709
    Event Type
    Death
    Date Received
    August 19, 2025
    Date of Event
    July 23, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648295164
    PMA / PMN Number
    P110019
    Report Source
    Manufacturer report
    Reporter Location
    UY
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER SEPARATE MEDWATCH REPORT NUMBER.

    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. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES AND SUBSEQUENT TREATMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE; HOWEVER, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. IT IS LIKELY THE DEVICE INTERACTED WITH THE PATIENT¿S CHALLENGING ANATOMY AND A PREVIOUSLY IMPLANTED STENT, WHICH CONTRIBUTED TO THE REPORTED DIFFICULTY IN ADVANCING AND REMOVING THE DEVICE. THE DEVICE MAY HAVE BEEN DAMAGED BY ANOTHER DEVICE OR BECOME ENTANGLED WITH PREVIOUSLY IMPLANTED STENT. ADDITIONALLY, A SNARE DEVICE WAS USED IN AN ATTEMPT TO REMOVE THE STENT; HOWEVER, ONLY PART OF THE STENT WAS REMOVED DUE TO MATERIAL SEPARATION (STENT), WHILE THE REMAINING PORTION BECAME LODGED IN THE ARTERY. THE REPORTED PATIENT EFFECT(S) OF ANGINA, CARDIAC ARREST, DEATH, EMBOLISM / EMBOLUS, MYOCARDIAL INFARCTION, PERFORATION OF VESSEL, THROMBOSIS/ THROMBUS ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS) INSTRUCTIONS FOR USE AS A KNOWN PATIENT EFFECT(S) OF CORONARY STENTING PROCEDURES. THE REVIEWER CONCLUDED THAT ¿AVAILABLE EVIDENCE DOES NOT SUGGEST THAT THE XIENCE SDS CAUSED THE FATAL OUTCOME. HOWEVER, THE ADVERSE EVENTS WERE MULTIFACTORIAL, AND THUS THE STENT SYSTEM MAY HAVE INDIRECTLY CONTRIBUTED TO PATIENT EXPIRATION. THERE IS NO INDICATION THAT THE XIENCE SDS HAD PERFORMANCE MECHANICAL FAILURES. KEY CONTRIBUTORS TO THE ADVERSE EVENTS INCLUDE COMPLEX CORONARY ANATOMY, CHALLENGES DURING STENT DELIVERY AND RETRIEVAL, AND SUBSEQUENT THROMBOTIC AND PERFORATION EVENTS. THE STENT¿S INABILITY TO CROSS THE LESION IS CONSISTENT WITH NAVIGATING CHALLENGING VASCULATURE¿SUCH AS ANGULATED LESIONS, HEAVY CALCIFICATION AND TORTUOSITY1,2. STUDIES SHOW THAT STENT LOSS OR MIGRATION CAN LEAD TO VESSEL PERFORATION OR OCCLUSION, OR MAJOR COMPLICATIONS INCLUDING MYOCARDIAL INFARCTION, PERICARDIAL EFFUSION, CARDIAC TAMPONADE AND DEATH2,3. THE ADVERSE OUTCOMES¿STENT ENTRAPMENT, THROMBOTIC OCCLUSION, AND PERFORATION¿ARE RELATED TO PROCEDURAL COMPLEXITY AND STENT RETRIEVAL MANEUVERS, NOT A FAILURE OF THE DEVICE TO PERFORM AS INTENDED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING; THEREFORE, NO PRODUCT-RELATED CORRECTIVE ACTION WILL BE IMPLEMENTED IN THIS CASE. D9 - DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO.

    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
    1435940 XIENCE PRO¿ S CORONARY DRUG-ELUTING STENT NIQ ABBOTT VASCULAR 1508225-28 4071741 08717648295164

    Patients

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