BEUDAMED
    FDA Adverse Event Death Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1833517 · Received September 3, 2010

    Report

    Report Number
    2024168-2010-01855
    Event Type
    Death
    Date Received
    September 3, 2010
    Date of Event
    August 6, 2010
    Report Date
    August 10, 2010
    Manufacturer
    ABBOTT VASCULAR CLONMEL
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE XIENCE V 4.0 X 28 MM (PART#1009531-28/LOT#0041341/SERIAL#52575), XIENCE V 3.5 X 28 MM (PART#1009530 12/LOT#0012741/SERIAL#51422), AND MULTI-LINK ZETA RX 3.0 X 38 MM (PART#1009838-38/LOT# UNK) MENTIONED ARE BEING FILED UNDER SEPARATE MFR REPORT NUMBERS. EVAL SUMMARY: IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED RESTENOSIS IS A KNOWN ADVERSE EVENT LISTED IN THE ZETA INSTRUCTIONS FOR USE (IFU). IN THIS CASE, THE RESTENOSIS WAS TREATED WITH DILATATION WHICH RESULTED IN A LONG DISSECTION. THREE XIENCE V STENTS WERE IMPLANTED TO TREAT THE DISSECTION. POST PROCEDURE, THE PT EXPIRED. IT SHOULD BE NOTED THAT THE DEATH IS LISTED AS A KNOWN ADVERSE EVENT IN THE ZETA IFU AND IN THE XIENCE V IFU. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PT EFFECTS AND THE RELATIONSHIP TO THE DEVICES, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. REPORTEDLY, THE 4.0 X 28 MM XIENCE V STENT DELIVERY SYSTEM (SDS) AND THE 4.0 X 12 MM XIENCE V SDS WERE INFLATED ABOVE RATED BURST PRESSURE (RBP). IT SHOULD BE NOTED THAT THE XIENCE V IFU STATES, "DO NOT EXCEED RBP". ADDITIONALLY, IT WAS REPORTED THAT THE 4.0 X 28 MM XIENCE V STENT WAS USED TO TREAT IN-STENT RESTENOSIS. IT SHOULD BE NOTED THAT THE XIENCE V IFU ALSO STATES THAT THE SAFETY AND EFFECTIVENESS OF TREATING IN-STENT RESTENOSIS HAS NOT BEEN ESTABLISHED. IT IS UNK IF THE INFLATIONS ABOVE RBP OR IMPLANTATION WITHIN IN-STENT RESTENOSIS CONTRIBUTED TO THE REPORTED COMPLAINT.

    Description of Event or Problem · 1

    ADVERSE EVENT: RESTENOSIS/DEATH. TIME OF ADVERSE EVENT: POST PROCEDURE. DEVICE ISSUE: NONE. IT WAS REPORTED THAT DURING THE PROCEDURE, INTRA-VASCULAR ULTRASOUND (IVUS) REVEALED PRIOR STENTING OF THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH A 3.0 X 38 MM ZETA WHICH HAD 31% IN-STENT RESTENOSIS. A 77% STENOSIS WAS REVEALED IN THE RIGHT CORONARY ARTERY (RCA). PRE-DILATATION WAS PERFORMED FROM THE MID TO OSTIAL RCA USING A NON-ABBOTT BALLOON WITH DEVELOPMENT OF A LONG DISSECTION. BAILOUT STENTING WAS PERFORMED USING A XIENCE V 3.5 X 28 MM STENT DEPLOYED AT 12 ATMOSPHERES. POST DILATATION WAS PERFORMED USING A NON-ABBOTT BALLOON. A SECOND XIENCE V 4.0 X 28 MM WAS DEPLOYED AT THE PROXIMAL TO MID LAD AT 18 ATMOSPHERES FOLLOWED BY DILATATION. A THIRD XIENCE V 4.0 X 12 MM STENT WAS DEPLOYED AT 20-30 ATMOSPHERES AT THE OSTIUM OF THE RCA. IVUS SHOWED FULLY DEPLOYED STENTS APPOSED TO THE ADJACENT VESSEL WALL. POST PROCEDURE, THE PT'S CONDITION WORSENED. CARDIOPULMONARY RESUSCITATION WAS PERFORMED; HOWEVER, THE PT DIED THAT SAME AFTERNOON. REPORTEDLY, PER PHYSICIAN, THE CAUSE OF DEATH COULD NOT BE DETERMINED. THOUGH REQUESTED, NO ADDITIONAL INFO HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR CLONMEL NA 9052741

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death GUIDE CATH: 5F.JL3.5| QUANTUM 4.0X12| DIL CATH: MAVERICK 3.5X20| MULTI-LINK ZETA RX 3.0 X 38MM| (PART#1009530-28/LOT#0012741/(B)(4))| (PART#1009531-28/LOT#0041341/(B)(4))| STENT: XIENCE V 4.0 X 28 MM| (PART#1009838-38/LOT# UNK)| STENT: XIENCE V 3.5 X 28 MM| GUIDE WIRE: RUNTHROUGH