BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1504675 · Received October 13, 2009

    Report

    Report Number
    2024168-2009-01835
    Event Type
    Injury
    Date Received
    October 13, 2009
    Date of Event
    August 17, 2009
    Report Date
    September 28, 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
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. DISSECTION, AS LISTED IN THE XIENCE V IFU, IS A KNOWN ADVERSE EVENT ASSOCIATED WITH CORONARY STENTING. DISSECTION IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY AND IN THIS CASE, THERE WAS NO REPORTED PRODUCT MALFUNCTION AT THE TIME OF IMPLANT. DISSECTION CAN BE INFLUENCED BY SEVERAL FACTORS SUCH AS PRODUCT SIZE SELECTION. IT SHOULD BE NOTED THAT THE IFU ALSO STATES: IMPLANTING A STENT MAY LEAD TO VESSEL DISSECTION AND ACUTE CLOSURE REQUIRING ADD'L INTERVENTION. A CLINICAL SPECIALIST REVIEWED THE CINE OF THE PROCEDURE, WHICH CONFIRMED THE REPORTED PROCEDURAL STEPS, INCLUDING THE PROXIMAL EDGE DISSECTION AND ITS TREATMENT BY TWO ADD'L STENTS. IT WAS CONCLUDED THAT THE DISSECTIONS APPEARED TO BE STENT-EDGE DISSECTIONS RATHER THAN THE REPORTED SPIRAL DISSECTION, BECAUSE THE CINE SHOWED A SLIGHT STEP-UP TO THE PROXIMAL EDGE OF THE PROXIMAL STENT AND STEP-DOWN TO THE DISTAL EDGE OF THE DISTAL STENT. THE CLINICAL SPECIALIST SUGGESTED THE FOLLOWING POSSIBLE CAUSES: FRAGILITY OF THE VESSELS, OVER-SIZED STENTS FOR THE VESSEL, OR THE RUPTURED BALLOON/SHAFT OF THE NC MERLIN. IN THIS CASE, A CONCLUSIVE CAUSE FOR THE DISSECTION AND THE RELATIONSHIP TO THE PRODUCTS, IF ANY, CANNOT BE DETERMINED. THE SECOND UNK XIENCE, IS BEING FILED UNDER THE SAME MFR#. THE NC MERLIN (PART# 82104-02, LOT# 564509), HAS BEEN FILED UNDER MFR# 2021468-2009-01647.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY -MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A SUBTOTAL OCCLUSION IN THE MID LAD. AFTER DEPLOYING 2 XIENCE V STENTS, THE NC MERLIN WAS BEING USED FOR POST-DILATATION. THE FIRST INFLATION WAS AT 16 ATM FOR 45 SEC. THE SECOND INFLATION WAS TO 16 ATM, BUT AT 42 SECONDS, THE BALLOON LOST PRESSURE AND BLOOD WAS SEEN COMING BACK INTO THE MANIFOLD. AT THIS POINT A DISSECTION WAS SUSPECTED, WHICH WAS CONFIRMED ON ANGIOGRAPHY TO BE PROXIMAL TO WHERE THE STENT OR BALLOON WAS INFLATED. WHEN THE CATHETER WAS REMOVED, A RUPTURE WAS NOTED IN THE DISTAL SHAFT. SINCE THE DISSECTION APPEARED TO HAVE SPIRALED ALL THE WAY DISTAL TO THE STENTS, TWO ADD'L XIENCE STENTS WERE IMPLANTED; ONE PROXIMAL AND ONE DISTAL. IT WAS FELT THAT THE DISSECTION OCCURRED AS A RESULT OF THE SHAFT RUPTURE. THERE WERE NO ADD'L PT EFFECTS. A CINE OF THE PROCEDURE WAS RETURNED FOR REVIEW. NO ADD'L EVENT OR PT INFO IS AVAILABLE. THE XIENCE STENTS ARE BEING REPORTED BASED ON THE CINE REVIEW OF THE PROCEDURE, WHICH STATES THAT THE DISSECTIONS MAY HAVE OCCURRED DUE TO OVER-SIZING THE VESSEL WITH THE XIENCE STENTS.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention (PART# 82104-02, LOT# 564509)| STABILIZER| DILITATION CATHETER: NC MERLIN| GUIDE WIRE: PROWATER| STENT: UNK XIENCE