BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2082337 · Received May 9, 2011

    Report

    Report Number
    2024168-2011-03311
    Event Type
    Injury
    Date Received
    May 9, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INDICATION FOR USE AND PATIENT SELECTION. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA, CARDIAC ARREST, DEATH, EKG CHANGES, AND THROMBOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE (IFU). 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. SINCE IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RECENT ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT, IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES: THE XIENCE V STENT IS CONTRAINDICATED FOR USE IN PATIENTS WHO HAD RECENT ACUTE MYOCARDIAL INFARCTION (AMI). IN ADDITION, SINCE IT WAS REPORTED THAT THE LESION WAS 40MM LONG, IT SHOULD BE NOTED THAT THE IFU STATES: THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 3.75 MM. THE IFU CAUTIONS THAT: THE SAFETY AND EFFECTIVENESS OF THE STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH LESION LENGTHS GREATER THAN 28 MM. IN THIS CASE, THE REPORTED IFU DEVIATIONS DO NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS THAT OCCURRED. .

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE PROMUS IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. ESTIMATED IMPLANT DATE OF (B)(6) 2011 WHICH WAS REPORTED AS (B)(6) 2011. THE STENT REMAINS IN THE PATIENT. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL INFORMATION RECEIVED, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: DURING THE INDEX PROCEDURE ON (B)(6), 2011, AFTER THE XIENCE V 2.5 X 23 MM STENT AND THE PROMUS 2.7 5X 23 MM STENT WERE IMPLANTED, INTRA-VASCULAR ULTRA SOUND (IVUS) WAS PERFORMED AND STENT APPOSITION WAS NOTED TO BE GOOD. ON (B)(6), 2011, DURING ANOTHER PROCEDURE TO TREAT A DIFFERENT LESION, THE PATIENT EXPERIENCED CHEST PAIN AND EKG CHANGES. SUB-ACUTE THROMBOSIS WAS NOTED AND BALLOONING AND ASPIRATION OF THE THROMBUS WAS PERFORMED. HOWEVER, THE PATIENT DIED DUE TO CARDIAC ARREST.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN (B)(6) 2011, A PROCEDURE WAS PERFORMED TO TREAT A PROXIMAL TO MID LEFT ANTERIOR DESCENDING LESION WITH HEAVY CALCIFICATION. ROTABLATOR WAS PERFORMED, AND A XIENCE V STENT AND A PROMUS STENT WERE IMPLANTED IN A MANNER THAT ONE STENT WAS OVERLAPPING THE OTHER. INTRA-VASCULAR ULTRA SOUND WAS PERFORMED. ON (B)(6) 2011, ANOTHER PROCEDURE WAS PERFORMED TO TREAT A DIFFERENT LESION. IN THIS PROCEDURE, THROMBOSIS WAS OBSERVED IN THE XIENCE V STENT AND PROMUS STENT AT THE OVERLAPPED POINT. THE THROMBOSIS WAS TREATED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT SEQUELAE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL INFORMATION RECEIVED, THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED. WHEN THE XIENCE AND PROMUS WERE DEPLOYED ON (B)(6) 2011, POST-DILATATION WAS PERFORMED TO COMPLETE THE PROCEDURE. NO MALPOSITION WAS OBSERVED.

    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 AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Death| H| R RX PROMUS