BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1923334 · Received December 13, 2010

    Report

    Report Number
    2024168-2010-02693
    Event Type
    Injury
    Date Received
    December 13, 2010
    Date of Event
    November 18, 2010
    Report Date
    November 18, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). STENT MIGRATION CAN BE A RESULT OF, BUT IS NOT LIMITED TO, INCORRECT DEVICE SIZE SELECTION, DEVICE PLACEMENT TECHNIQUE, THE STENT NOT BEING FULLY APPOSED TO THE VESSEL WALL AND/OR INTERACTION WITH OTHER DEVICES. HOWEVER, SINCE ALL STENT DELIVERY SYSTEMS ARE 100% INSPECTED FOR DAMAGE DURING THE MANUFACTURING PROCESS AND A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED PRIOR TO RELEASE TO VERIFY PROPER STENT DEPLOYMENT, THIS SUGGESTS THERE IS NO PRODUCT DEFICIENCY. BASED ON THE INFORMATION PROVIDED, A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTY CANNOT BE DETERMINED. ADDITIONALLY, NO PRE-DILATATION WAS PERFORMED DURING THE PROCEDURE. IT SHOULD BE NOTED THAT THE XIENCE V INSTRUCTIONS FOR USE (IFU) STATES: PRE-DILATE THE LESION WITH A PTCA CATHETER OF APPROPRIATE LENGTH AND DIAMETER FOR THE VESSEL / LESION TO BE TREATED. IN THIS CASE, IT IS UNKNOWN IF THE LACK OF PRE-DILATATION CONTRIBUTED TO THE REPORTED STENT MIGRATION, ALTHOUGH PRE-DILATATION MAY HAVE ASSISTED IN THE APPOSITION OF THE STENT DURING DEPLOYMENT; HOWEVER, THIS CANNOT BE CONFIRMED. A CONCLUSIVE CAUSE FOR THE REPORTED STENT MIGRATION COULD NOT BE DETERMINED. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NON-CONFORMITIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DIL CATH: QUANTUM MAVERICK 3.0-8; GUIDE WIRE: ROUTE, SIONBLUE; GUIDE CATH: LAUNCHER 7F EBU3.5; STENT: XIENCE V 2.5-12. (B)(4) (NO PRE-DILATATION) THE STENT REMAINS IN THE PATIENT. THE LOT NUMBER WAS PROVIDED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    CUSTOMER'S FATHER REPORTED CUSTOMER EXPERIENCED A MEDICAL EVENT THAT OCCURRED BETWEEN (B)(6), 2010 AND (B)(6), 2010. HE FURTHER REPORTED CUSTOMER RECEIVED A READING OF 254 MG/DL ON HER FREESTYLE FREEDOM BLOOD GLUCOSE METER AND "PROCEEDED WITH HER TREATMENT PROGRAM". HE NOTED THE CUSTOMER USES AN INSULIN PUMP. IT WAS FURTHER REPORTED THAT "AT SOME POINT" ON (B)(6), 2010 CUSTOMER EXPERIENCED A LOSS OF CONSCIOUSNESS, EXTREME DEHYDRATION AND WENT INTO A COMA. CUSTOMER WAS TRANSPORTED BY A FRIEND TO A LOCAL HEALTHCARE FACILITY. AT THE FACILITY A BLOOD GLUCOSE RESULT OF 1348 MG/DL WAS RECEIVED. CUSTOMER WAS DIAGNOSED WITH SEVERE HYPERGLYCEMIA AND DKA (DIABETIC KETOACIDOSIS). IT IS UNKNOWN WHAT TREATMENT WAS GIVEN AT THE FACILITY. THERE WAS NO REPORT OF DEATH OR PERMANENT INJURY ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MID CIRCUMFLEX ARTERY, INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED FOLLOWED BY XIENCE V DIRECT STENTING. POSITIONING THE STENT EDGE AT THE OSTIUM OF THE CIRCUMFLEX, THE STENT SYSTEM BALLOON WAS INFLATED. AFTER STENT DEPLOYMENT, ANGIOGRAPHY REVEALED THAT THE STENT EDGE WAS IN THE LEFT CIRCUMFLEX. THERE WAS NO ADVERSE PATIENT EFFECT. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS 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 9102061

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other CONCOMITANT MEDICAL DEVICES