BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932357 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02817
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 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): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. : DILATATION CATHETER: 1.25 TAZUNA, 3.0 X 15 MM HIRYU; GUIDE WIRE: RUNTHROUGH, PT2MS; GUIDE CATH: LAUNCHER 6F SAL SH; INTRODUCER SHEATH: TERUMO 6F; STENT: ENDEAVOR 3.0X15MM (B)(4): RE-INSERTION OF THE DEVICE THE INABILITY TO CROSS A LESION CAN BE THE RESULT OF, BUT NOT LIMITED TO, PATIENT ANATOMICAL CONDITIONS, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION AND ACCESSORY DEVICE SUPPORT. THE STENT DELIVERY SYSTEM (SDS) WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE EVALUATION. THE ANATOMICAL CONDITIONS WERE REPORTED TO BE HEAVILY TORTUOUS. IN THIS CASE, BECAUSE THE LESION HAD BEEN PRE-DILATED MULTIPLE TIMES AND THE SDS WOULD STILL NOT CROSS SUGGESTS CHALLENGING ANATOMICAL CONDITIONS, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO CROSS. HOWEVER, THE SDS WAS NOT RETURNED TO ABBOTT VASCULAR FOR ANALYSIS AND MAY HAVE ASSISTED IN THE INVESTIGATION. THE STENT WAS REPORTED TO HAVE BEEN DISLODGED AND REMAINED IN THE MID RIGHT CORONARY ARTERY (RCA). THE PROMUS SDS WAS REMOVED FORM THE BODY TO PERFORM ADDITIONAL PRE-DILATATION OF THE LESION AND WAS THEN RE-INSERTED FOR AN ADDITIONAL ATTEMPT TO CROSS THE LESION. ONCE IT WAS REMOVED, IT WAS NOTICED THAT THE STENT HAD DISLODGED. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE (IFU) STATES THAT AN UNEXPANDED STENT MAY BE RETRACTED INTO THE GUIDING CATHETER ONE TIME ONLY. AN UNEXPANDED STENT SHOULD NOT BE REINTRODUCED INTO THE ARTERY ONCE IT HAS BEEN PULLED BACK INTO THE GUIDING CATHETER. SUBSEQUENT MOVEMENT IN AND OUT THROUGH THE DISTAL END OF THE GUIDING CATHETER SHOULD NOT BE PERFORMED AS THE STENT MAY BE DAMAGED OR/AND DISLODGED FROM THE BALLOON WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. IT APPEARS THAT THE RE-INSERTION OF THE PROMUS SDS LIKELY CONTRIBUTED TO THE REPORTED STENT DISLODGEMENT IN THE MID RCA. THE REPORTED FAILURE TO CROSS AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE CIRCUMSTANCE OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION WAS PERFORMED TWICE USING A NON-ABBOTT BALLOON CATHETER. THE PROMUS STENT DELIVERY SYSTEM (SDS) WAS UNABLE TO CROSS THE LESION; THEREFORE, A NON-ABBOTT GUIDE WIRE WAS INSERTED USING A PARALLEL WIRE TECHNIQUE WITH THE PROMUS SDS; HOWEVER THE SDS FAILED TO CROSS. THE VESSEL WAS DILATED TWICE MORE WITH THE BALLOON CATHETER, BUT THE PROMUS SDS STILL COULD NOT CROSS THE LESION. AFTER REMOVAL OF THE PROMUS SDS FROM THE PATIENT, IT WAS NOTED THAT THE STENT WAS NO LONGER ON THE BALLOON. ULTRASOUND REVEALED THAT THE STENT HAD DISLODGED IN THE MID RIGHT CORONARY ARTERY (RCA). NON-ABBOTT BALLOON CATHETERS WERE USED TO DEPLOY THE DISLODGED STENT INTO THE VESSEL AND AN ADDITIONAL NON-ABBOTT STENT WAS IMPLANTED IN THE DISTAL RCA TO COMPLETE THE PROCEDURE. THE PATIENT IS WELL. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

    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 0071561

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CONCOMITANT MEDICAL DEVICES