BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2220959 · Received August 23, 2011

    Report

    Report Number
    2024168-2011-05920
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    July 26, 2011
    Report Date
    August 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. CONCOMITANT MEDICAL PRODUCTS: STENT: TAXUS 2.5 X 12 MM, PROMUS 2.5 X 18 MM, XIENCE V 3.0 X 18 MM AND 2.5 X 8 MM, VISION 2.75 X 28 MM. THE 2.5 X 8 MM XIENCE V AND THE 2.75 X 28 MM VISION ARE BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. (B)(4) - INDICATION FOR USE. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA AND RE-STENOSIS ARE LISTED IN THE XIENCE V INSTRUCTIONS FOR USE AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IT WAS REPORTED THAT THE STENT WAS IMPLANTED TO TREAT RE-STENOSIS OF A PREVIOUSLY IMPLANTED STENT. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES THAT THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (XIENCE V STENT) 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 4.25 MM. THE IMPLANTATION OF THE STENT TO TREAT IN-STENT RESTENOSIS DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2005, A NON-ABBOTT STENT WAS IMPLANTED IN THE FIRST DIAGONAL ARTERY. ON (B)(6) 2006, A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) WAS PERFORMED IN THE FIRST DIAGONAL AND A VISION 2.75 X 28 MM STENT WAS IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (MLAD). ON (B)(6) 2008, A PTCA WAS PERFORMED IN THE FIRST DIAGONAL ARTERY AND IN THE MLAD. ON (B)(6) 2008, THE PATIENT WAS HOSPITALIZED WITH CHEST PAIN, NECK PAIN AND SHORTNESS OF BREATH AND UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION WITH XIENCE V STENTING IN THE FIRST DIAGONAL ARTERY WITH ONE 2.5 X 8 MM STENT AND IN THE MLAD WITH ONE 2.75 X 28 MM STENT; BOTH LESIONS WERE RESTENOSED, PREVIOUSLY STENTED LESIONS. ON (B)(6) 2009, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE PROXIMAL RIGHT CORONARY ARTERY WITH ONE PROMUS 2.5 X 18 MM STENT. ON (B)(6) 2010, THE PATIENT UNDERWENT PERCUTANEOUS CORONARY REVASCULARIZATION IN THE MID RIGHT CORONARY ARTERY WITH ONE XIENCE V 3.0 X 18 MM STENT. ON THE (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR RECURRENT ANGINA AND UNDERWENT CORONARY ARTERY BYPASS GRAFTING OF THE DISTAL RCA, LAD (70% STENOSIS) AND THE DIAGONAL (70% STENOSIS). THE PATIENT WAS TRANSFUSED WITH FOUR UNITS OF BLOOD. THE PATIENT'S CONDITION RESOLVED AND THE PATIENT WAS DISCHARGED ON (B)(6) 2011. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    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 7112141

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R| S