BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1899463 · Received November 9, 2010

    Report

    Report Number
    2024168-2010-02404
    Event Type
    Death
    Date Received
    November 9, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. CARDIAC ARREST, DEATH, EKG CHANGES, HEMORRHAGE, PERFORATION, CARDIAC TAMPONADE, AND ARRHYTHMIA (INCLUDES VENTRICULAR FIBRILLATION) ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION IS THE DISTAL CX, WITH MILD TORTUOSITY, MILD CALCIFICATION, A 90% STENOSIS, ECCENTRIC, AND A DE NOVO LESION. AFTER PRE-DILATATION, THE 3.5X23 MM XIENCE V STENT WAS DELIVERED AND IMPLANTED. ST SEGMENT ELEVATION AND VF (VENTRICULAR FLUTTER) WAS NOTED AFTER THE STENT WAS IMPLANTED, WHICH WAS TREATED WITH CARDIAC MASSAGE AND DEFIBRILLATION. A CORONARY PERFORATION WAS FOUND AT THE DISTAL SIDE OF THE IMPLANTED XIENCE V STENT, POSSIBLY DUE TO THE PATIENT'S FRAGILE VESSEL. PCPS (PERCUTANEOUS CARDIOPULMONARY SUPPORT BYPASS) WAS USED IN COMBINATION, AND THE GRAFTMASTER WAS DELIVERED TOWARD THE LESION AND SUCCESSFULLY DEPLOYED TO TREAT THE PERFORATION. CARDIAC TAMPONADE OCCURRED REQUIRING PERICARDIOCENTESIS. AFTER THE BLEEDING WAS CONFIRMED TO BE STOPPED, THE PCPS WAS REMOVED, BUT RIGHT AFTER THE REMOVAL, THE DAMAGE WAS CONFIRMED AT INFERIOR VENA CAVA, SO THE PCPS WAS SET AGAIN, AND SUTURATION (SURGERY) WAS PERFORMED. DURING THE SUTURATION, THE PHYSICIAN NEEDED TO APPROACH FROM ABDOMINAL AREA. DURING THE APPROACH, THERE WAS A BLEEDING FROM THE LIVER (WHEN TRYING TO TUG THE LIVER). BECAUSE OF THESE BLEEDINGS, THE PT DIED OF LOSS OF BLOOD ON (B)(6) 2010. NO ADD'L INFO WAS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING LOW VALPROIC ACID (VPA) RESULTS GENERATED BY THE UNICEL DXC 600I SYNCHRON® ACCESS CLINICAL SYSTEMS FOR ONE PATIENT. THE INITIAL VPA RESULT WAS REPORTED OUT OF THE LAB AND WAS QUESTIONED BY THE PHYSICIAN. TWO RE-DRAW SAMPLES WERE COLLECTED; HOWEVER THE INSTRUMENT STILL YIELDED INCONSISTENT RESULTS. THE CUSTOMER SENT ONE SAMPLE TO A DIFFERENT LAB AND A HIGHER RESULT WAS OBTAINED. PATIENT TREATMENT WAS NOT IMPACTED. PHYSICIAN DID NOT BELIEVE THE RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR - CARDIAC THERAPIES NA 0061541

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death| R ATLANTIS PRO SR| GUIDE CATHETER: AXESS 6F JL3.5| GUIDE WIRE: BMW HC