BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2240183 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06214
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. FACTORS THAT CAN CONTRIBUTE TO THE DIFFICULTY TO DEPLOY (WATERMELON SEEDING) INCLUDE, BUT ARE NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, AND PROCEDURAL INFLATION TECHNIQUE. THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED FOR ANALYSIS WHICH MAY HAVE ASSISTED IN THE INVESTIGATION. THE PATIENT ANATOMY WAS HEAVILY CALCIFIED WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTIES. ADDITIONALLY, AS INFLATION WAS ATTEMPTED, THIS WOULD PARTIALLY EXPAND THE STENT AND AS THE SDS WAS RETRACTED, THE PARTIALLY EXPANDED STENT WOULD BE LOOSE AND DISLODGE FROM THE BALLOON. THE DISLODGED STENT WAS NOT RETRIEVED FROM THE PATIENT ANATOMY. A SEARCH OF THE LOT HISTORY RECORD INDICATED NO NON-CONFORMING MATERIAL REPORTS FOR THE LOT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT AND A SEARCH OF THE COMPLAINT DATABASE INDICATED NO RELATED INCIDENTS. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. TO ENSURE THIS ISSUE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, A SAMPLING OF UNITS IS TESTED TO VERIFY PROPER STENT DEPLOYMENT AND UNIFORMITY OF EXPANSION.

    Additional Manufacturer Narrative · 1

    (B)(6),

    Description of Event or Problem · 1

    REPORTEDLY DURING INFLATION OF THE XIENCE V IN THE OSTIAL OF A HEAVILY CALCIFIED RIGHT CORONARY ARTERY, THE XIENCE V WATERMELON SEEDED SO THE STENT AND BALLOON CATHETER WERE ATTEMPTED TO BE PULLED BACK INTO A NON-ABBOTT GUIDING CATHETER; HOWEVER, THE XIENCE V STENT MIGRATED TO THE SUPERFICIAL FEMORAL ARTERY (SFA). A VASCULAR SURGEON REVIEWED THE IMAGES AND THE LOCATION OF THE XIENCE V STENT IN THE SFA AND FELT IT WOULD NOT CAUSE ANY COMPLICATIONS SO IT WAS DECIDED THAT NO FURTHER TREATMENT WOULD BE ADMINISTERED TO TRY AND SNARE THE STENT. THE PROCEDURE WAS COMPLETED USING ANOTHER XIENCE V. THERE WERE NO ADVERSE PATIENT EFFECTS DUE TO THE EVENT AND A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL MEDWATCH REPORT BEING FILED, ADDITIONAL INFORMATION WAS RECEIVED VIA A USER FACILITY MEDWATCH WHICH STATED, "TWO CORONARY STENTS WERE PLACED IN THE PATIENT. DURING PLACEMENT OF THIRD STENT TO THE OSTIUM OF RIGHT CORONARY ARTERY, THE BALLOON "WATERMELONED" BACK INTO GUIDE WHILE THE BALLOON WAS INFLATED. THIS CAUSED THE STENT TO COME OFF THE BALLOON AND BECOME LODGED IN THE GUIDE. THE ENTIRE SYSTEM WAS REMOVED THROUGH THE SHEATH. IT WAS THOUGHT THAT THE STENT WAS IN THE GUIDE BUT IT WAS NOT FOUND. UPON FLOUROSCOPY OF THE RIGHT LEG, THE STENT WAS VISUALIZED IN THE RIGHT LEG PROFINDA. THE DECISION WAS MADE TO LEAVE THE STENT ALONE."

    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 1030141

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other