BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 10474176 · Received August 31, 2020

    Report

    Report Number
    2024168-2020-07245
    Event Type
    Death
    Date Received
    August 31, 2020
    Date of Event
    August 3, 2020
    Report Date
    August 31, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIQ
    UDI-DI
    08717648227431
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF PERFORATION, CARDIAC FAILURE (CARDIAC ARREST), HYPOTENSION AND DEATH ARE LISTED IN THE XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEMS INSTRUCTIONS FOR USE AS KNOWN PATIENT EFFECTS OF CORONARY PROCEDURES. A MEDICAL REVIEW WAS PERFORMED BY AN ABBOTT VASCULAR CLINICAL SPECIALIST. THE MAIN CAUSE OF DEATH WAS SECONDARY TO THE PERFORATION WHICH WAS CAUSED BY THE 3.5 X 23MM XIENCE SIERRA STENT. THE LESION CALCIFICATION WAS NOT MENTIONED BUT I WOULD PRESUME THAT IT IS MODERATELY TO SEVERE BECAUSE THEY ARE USING ROTABLATION ATHERECTOMY WHICH ALSO COULD HAVE CONTRIBUTED TO THE PERFORATION. HENCE, XIENCE SIERRA DIRECTLY CONTRIBUTED TO THE OUTCOME OF DEATH BUT PROCEDURAL COMPLICATIONS AND PATIENT¿S DISEASE BURDEN HAVE ALSO CONTRIBUTED TO PATIENT¿S DEMISE. FAILURE TO ADVANCE CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING BUT NOT LIMITED TO PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, AND ACCESSORY DEVICE SUPPORT. THE PRODUCT RISK ASSESSMENT IDENTIFIES THIS AS A FORESEEABLE EVENT; AS SUCH, DESIGN AND MANUFACTURING CONTROLS AND MITIGATIONS HAVE BEEN ESTABLISHED FOR POTENTIAL CAUSES. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED FAILURE TO ADVANCE CANNOT BE DETERMINED. ADDITIONALLY, IT IS POSSIBLE THE REPORTED DIFFICULTIES CONTRIBUTED TO THE REPORTED PATIENT EFFECTS; HOWEVER A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE WAS NO DAMAGE NOTED TO THE DEVICE DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTIES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE TWO GRAFTMASTER STENT SYSTEMS ARE FILED UNDER SEPARATE MEDWATCH REPORT NUMBERS (2024168-2020-07060, 2024168-2020-07098).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LEFT ANTERIOR DESCENDING CORONARY ARTERY INTERVENTION, A 3.5 X 23MM XIENCE SIERRA STENT WAS ADVANCED BUT FAILED TO REACH THE LESION. ANGIOGRAPHY SHOWED A SIGNIFICANT PERFORATION. PATIENT BECAME HYPOTENSIVE AND WENT INTO CARDIAC ARREST. CARDIOPULMONARY RESUSCITATION WAS PERFORMED, AND A TEMPORARY PACEMAKER WAS PLACED, SUCCESSFULLY REVIVING THE PATIENT. A 3.5X26MM GRAFTMASTER STENT SYSTEM WAS ADVANCED BUT FAILED TO REACH THE PERFORATION AND WAS REMOVED WITHOUT ISSUE. TWO ADDITIONAL GRAFTMASTER STENTS (3.5X19MM, 3.5X16MM) WERE ADVANCED AND SUCCESSFULLY SEALED THE PERFORATION; HOWEVER, A DISTAL EDGE DISSECTION WAS NOTED. A 3X12MM XIENCE SIERRA STENT WAS IMPLANTED TO SUCCESSFULLY TREAT THE DISSECTION. ADDITIONALLY, DURING THIS PROCEDURE, IT WAS NOTED THAT THE PATIENT HAD SEVERE AORTIC STENOSIS AND WAS PLACED ON AN INTRA-ARTERIAL BALLOON PUMP. AORTIC BALLOON VALVOPLASTY WAS PERFORMED, WITH GOOD RESULTS. POST-PROCEDURE, THE PATIENT REMAINED IN CRITICAL CONDITION WITH A POOR PROGNOSIS. LATER THAT EVENING, THE PATIENT DIED FROM PULSELESS ELECTRICAL ACTIVITY. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    936558 XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM NIQ ABBOTT VASCULAR 1550350-23 08717648227431

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death