BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2151991 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04790
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. GUIDE WIRE: KINETIX. GUIDE CATH: LAUNCHER 6 F EBU 3.5. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ABILITY TO ADVANCE THE STENT DELIVERY SYSTEM (SDS) TO A LESION CAN BE IMPACTED IN NUMEROUS WAYS. SOME OF THE CONTRIBUTING FACTORS MAY CONSIST OF, BUT NOT LIMITED TO, PATIENT ANATOMICAL CONDITION, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. THE PRODUCT WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. IN THIS CASE, IT WAS REPORTED THAT THE NON-ABBOTT GUIDING CATHETER WAS KINKED IN TWO PLACES (DIFFICULT TO POSITION) LOCATED AT THE SUBCLAVIAN ARTERY. AN ATTEMPT WAS MADE TO REMOVE THE SDS AND RESISTANCE (DIFFICULTY TO REMOVE) WAS FELT AND FORCE WAS APPLIED WHICH SUBSEQUENTLY RESULTED IN THE STENT DISLODGEMENT IN THE GUIDING CATHETER. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: IF UNUSUAL RESISTANCE IS FELT BEFORE THE STENT EXITS THE GUIDING CATHETER, DO NOT FORCE PASSAGE. RESISTANCE MAY INDICATE A PROBLEM AND THE USE OF EXCESSIVE FORCE MAY RESULT IN STENT DAMAGE OR DISLODGEMENT. MAINTAIN GUIDE WIRE PLACEMENT ACROSS THE LESION AND REMOVE THE DELIVERY SYSTEM AND GUIDING CATHETER AS A SINGLE UNIT. IN THIS CASE, IT APPEARS THAT THE USE OF FORCE DURING REMOVAL CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ISSUED FOR THIS LOT. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS HAVE BEEN REPORTED FOR DIFFICULT TO POSITION, DIFFICULT TO REMOVE OR STENT DISLODGEMENT FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY ASSOCIATED WITH THIS LOT. THE REPORTED DIFFICULT TO POSITION, STENT DISLODGEMENT AND DIFFICULTY TO REMOVE APPEAR TO BE RELATED TO THE PROCEDURE CIRCUMSTANCES AND THERE ARE NO INDICATIONS OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN THE MODERATELY CALCIFIED PROXIMAL CIRCUMFLEX ARTERY, RIGHT RADIAL ACCESS, PRE-DILATATION WAS PERFORMED. A 2.75 X 12 RX PROMUS DELIVERY CATHETER WAS ADVANCED; HOWEVER, IT WAS NOTED THAT THE NON-ABBOTT GUIDE CATHETER WAS KINKED IN TWO PLACES AT THE LOCATION OF THE SUBCLAVIAN. AN ATTEMPT WAS MADE TO WITHDRAW THE DELIVERY CATHETER THROUGH THE GUIDE CATHETER, RESISTANCE WAS FELT AND FORCE WAS APPLIED. THE STENT DISLODGED IN THE GUIDE CATHETER. THE DEVICES WERE REMOVED AS A SINGLE UNIT AND A NEW PROMUS STENT SYSTEM WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO REPORTED SIGNIFICANT CLINICAL DELAY IN THE PROCEDURE. ALTHOUGH REQUESTED, NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9092441

    Patients

    Seq Age Sex Outcome Treatment
    1