BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1477279 · Received July 17, 2009

    Report

    Report Number
    2024168-2009-01667
    Event Type
    Injury
    Date Received
    July 17, 2009
    Date of Event
    August 7, 2009
    Report Date
    August 25, 2009
    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
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L RX XIENCE V 3.0 X 15 MM (PART#1009541-15/LOT#8052161) AND RX XIENCE V 3.0 X 23 MM (PART#1009541-23/LOT#8052842), IS BEING FILED UNDER THE SAME MFG NUMBER. THE 3.5 X 15 MM XIENCE V STENT WAS USED TO TREAT RESTENOSIS OF A PREVIOUSLY IMPLANTED VISION STENT. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH = 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE IFU ALSO MENTIONS THAT THE SAFETY AND EFFECTIVENESS OF THE XIENCE V STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. THE PATIENT EFFECT OF STENOSIS AND PAIN, AS LISTED IN THE IFU, ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES AND ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALTHOUGH HOSPITALIZATION IS NOT SPECIFICALLY ADDRESSED IN THE IFU, IT IS LISTED IN THE NO-FAULT RISK ASSESSMENT IN ADDITIONS TO STENOSIS AND PAIN, AS POTENTIAL POST-PROCEDURE COMPLICATIONS ASSOCIATED WITH CORONARY STENTING. SINCE THERE WAS NO REPORT OF ANY PRODUCT MALFUNCTION IDENTIFIED DURING THE PROCEDURE THAT COULD HAVE CONTRIBUTED TO THE REPORTED PATIENT EFFECTS, THERE DOES NOT APPEAR TO BE ANY INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, THE NEED FOR HOSPITALIZATION APPEARS TO HAVE BEEN A SECONDARY EFFECT OF THE STENOSIS, WHICH REQUIRED TREATMENT WITH ADDITIONAL PERCUTANEOUS CORONARY INTERVENTION (PCI). FURTHERMORE, THE REPORTED BACK PAIN MAY BE ASSOCIATED WITH MANY OTHER THINGS BESIDES THE XIENCE V STENTS SUCH AS THE OVERALL HEALTH AND CONDITION OF THE PATIENT OR OTHER MEDICATIONS PRESCRIBED TO THE PATIENT. BACK PAIN IS ALSO A NOTED SIDE EFFECT OF THE MEDICATION CLOPIDOGREL (PLAVIX), WHICH IS LISTED AS ONGOING TREATMENT FOR THIS PATIENT. IN THIS INSTANCE, ALTHOUGH THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY- MEDICAL INTERVENTION. REPORTING RATIONALE: RESTENOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED VIA A TRIAL THAT THE PATIENT UNDERWENT STENTING WITH A 3.5 X 15 MM RX XIENCE V STENT DELIVERY SYSTEM (SDS) TO TREAT RESTENOSIS OF A PREVIOUSLY IMPLANTED VISION STENT IN THE MID RIGHT CORONARY ARTERY (RCA). A 3.0 X 15 MM AND A 3.0 X 23 MM XIENCE V STENT WERE ALSO IMPLANTED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD) AND THE DIAGONAL BRANCH DURING THE INDEX PROCEDURE. IN 2009, THE PATIENT COMPLAINED OF BACK PAIN BETWEEN THE SHOULDER BLADES. PTCI WAS PERFORMED TO TREAT THE TARGET VESSEL (RESTENOSIS). NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8051941

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R RX XIENCE V 3.0 X 15 MM| RX XIENCE V 3.0 X 23 MM| (PART#1009541-23/LOT#8052842)| (PART#1009541-15/LOT#8052161)