BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3140696 · Received May 31, 2013

    Report

    Report Number
    2024168-2013-03421
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    March 26, 2013
    Report Date
    May 8, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P110019
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. CONCOMITANT MEDICAL PRODUCTS: GUIDE WIRE: ALLSTAR; GUIDE CATH: 6F MEDTRONIC. (B)(4) - INCORRECT ANATOMY. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (IFU) STATES: XIENCE XPEDITION IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. ADDITIONALLY, THE IFU STATES THAT: THE SAFETY AND EFFECTIVENESS OF THE XIENCE XPEDITION STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH SAPHENOUS VEIN GRAFTS. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION - IT WAS INITIALLY REPORTED THAT THE DEVICE WOULD BE NOT BE RETURNED FOR ANALYSIS. SUBSEQUENT INFORMATION REVEALED THAT THE DEVICE IS AVAILABLE FOR EVALUATION. EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. FAILURE TO ADVANCE/CROSS THE LESION COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. STENT DISLODGMENT WAS CONFIRMED. BASED ON VISUAL AND DIMENSIONAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. IT SHOULD BE NOTED THAT THE XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM (IFU) STATES: XIENCE XPEDITION IS INDICATED FOR IMPROVING CORONARY ARTERY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. ADDITIONALLY, THE IFU STATES: THE SAFETY AND EFFECTIVENESS OF THE XIENCE XPEDITION STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH SAPHENOUS VEIN GRAFTS. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A RIGHT CORONARY ARTERY GRAFT. A 6F NON-ABBOTT GUIDING CATHETER AND AN ALLSTAR GUIDE WIRE WERE PLACED. PRE-DILATATION WAS PERFORMED WITH A 2.5 X 12 MM NON-ABBOTT BALLOON CATHETER PRESSURIZED TO 10 AND THEN 12 ATMOSPHERES. INFLATION TIME WAS UNKNOWN. A 4.0 X 18 MM XIENCE XPEDITION WAS ADVANCED TO THE LESION; HOWEVER, IT COULD NOT CROSS AND THE STENT IMPLANT DISLODGED. AN ATTEMPT WAS MADE TO RETRIEVE THE STENT IMPLANT BUT IT COULD NOT BE REMOVED AND IS FLOATING IN THE LEG. THE GUIDE WIRE AND GUIDING CATHETER WERE EXCHANGED FOR NEW ONES AND THE LESION WAS PRE-DILATATED AGAIN WITH A 2.5 X 12 MM NON-ABBOTT BALLOON CATHETER AND A 2.5 X 18 MM NON-ABBOTT STENT WAS IMPLANTED. POST-DILATATION WAS PERFORMED WITH A 4.0 X 15 MM NON-ABBOTT BALLOON CATHETER. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241863 XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 2111341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention