BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1901237 · Received November 17, 2010

    Report

    Report Number
    2024168-2010-02455
    Event Type
    Malfunction
    Date Received
    November 17, 2010
    Date of Event
    October 19, 2010
    Report Date
    October 20, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROMUS STENT DELIVERY SYSTEM WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED PROMUS STENT DELIVERY SYSTEM (SDS) NOTED BLOOD VISIBLE ON THE STENT AND CONTRAST IN THE INFLATION LUMEN, WHICH IS CONSISTENT WITH PREPARATION AND THE SDS ADVANCED INTO THE PATIENT ANATOMY. THE STENT WAS DISLODGED FROM THE BALLOON AND LOOSE ON THE DISTAL SHAFT. THE FIRST THREE ROWS OF DISTAL STRUTS WERE MANGLED. THE ENTIRE LENGTH OF THE STENT WAS SLIGHTLY SMASHED. CRIMP MARKS WERE VISIBLE ON THE TIGHTLY FOLDED BALLOON BETWEEN THE MARKERS, SUGGESTING THAT THE STENT WAS ORIGINALLY POSITIONED CORRECTLY AND SECURELY AT THE TIME OF MANUFACTURE. THE PROXIMAL BALLOON SHOULDER WAS BUNCHED, THERE WAS A KINK IN THE DISTAL SHAFT, AND THE SOFT TIP WAS STRETCHED AND JAGGED. SINCE THIS DAMAGE WAS NOT REPORTED IN THE INCIDENT INFORMATION, THE KINK MAY HAVE OCCURRED DURING THE PROCEDURE OR DURING PACKAGING, HANDLING AND RETURN TO ABBOTT VASCULAR FOR ANALYSIS. THE TIP LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. THE STENT OUTER DIAMETERS COULD NOT BE MEASURED DUE TO THE DAMAGE NOTED. ADDITIONALLY, THE SDS COULD NOT BE ADVANCED THROUGH A NEW GUIDING CATHETER DUE TO THE LOOSE STENT. THE INABILITY TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. REPORTEDLY, THE LESION WAS MODERATELY TORTUOUS AND CALCIFIED, WHICH LIKELY CONTRIBUTED TO THE REPORTED FAILURE TO ADVANCE. ADDITIONALLY, IT WAS REPORTED THE PROMUS SDS WAS USED IN THE ATTEMPT TO TREAT IN-STENT RESTENOSIS OF AN UNKNOWN STENT. IT SHOULD BE NOTED THE PROMUS INSTRUCTIONS FOR USE (IFU) STATES: SAFETY AND EFFECTIVENESS OF THE PROMUS STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. IT IS LIKELY AN INTERACTION WITH THE LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE MODERATELY TORTUOUS AND CALCIFIED LESION MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE TO THE STENT. FURTHER, DURING RE-INSERTION OF THE SDS, THE DAMAGED STENT STRUTS WOULD HAVE THEN INTERACTED WITH THE GUIDE LINER AND FURTHER CONTRIBUTING TO THE STENT DISLODGING PROXIMALLY ONTO THE DISTAL SHAFT. IT SHOULD BE NOTED THE IFU STATES: 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 WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE REPORTED FAILURE TO ADVANCE, DIFFICULT TO POSITION, AND STENT DISLODGEMENT APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. THE PROFILE DIMENSIONS ON ALL STENT DELIVERY SYSTEMS ARE CONFIRMED BY VISUAL AND DIMENSIONAL CHECKS ON THE MANUFACTURING LINE BEFORE RELEASE. ALL STENT DELIVERY SYSTEMS ARE 100% VISUALLY INSPECTED ONLINE FOR STENT PLACEMENT. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY STENT DISLODGEMENT FORCE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRE-DILATATION IN THE CALCIFIED CIRCUMFLEX ARTERY AN UNK VOYAGER BALLOON RUPTURED AT 8 ATMOSPHERES AND A PERFORATION OCCURRED. VENTRICULAR TACHYCARDIA OCCURRED AND THE PATIENT WAS INTUBATED. AN UNK GRAFTMASTER COULD NOT BE ADVANCED TO TREAT THE LESION. DURING GRAFTMASTER REMOVAL THE GUIDE CATHETER CAME OUT OF THE LEFT MAIN OSTIUM. THE GRAFTMASTER STENT DISLODGED FROM THE DELIVERY SYSTEM, FLOATING ON THE GUIDE WIRE. ALL DEVICES INCLUDING THE GUIDE WIRE WERE REMOVED; HOWEVER, THE DISLODGED STENT CAME OFF OF THE GUIDE WIRE IN THE PROFUNDA. STENT STILL REMAINS LOOSE IN THE PROFUNDA. AN UNK ABBOTT BARE METAL STENT (BMS) WAS IMPLANTED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION, DELAYING THE PROCEDURE. A SECOND UNK GRAFTMASTER WAS IMPLANTED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION. A THIRD UNK GRAFTMASTER WAS IMPLANTED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION. AN UNK 3X5 VOYAGER BALLOON WAS INFLATED BUT WAS UNSUCCESSFUL IN SEALING THE PERFORATION, DELAYING THE PROCEDURE. A 4.0 NC MERLIN WAS INFLATED TO 20 ATMOSPHERES AND SUCCESSFULLY SEALED THE LESION. PERICARDIOCENTESIS WAS PERFORMED WITH 500 CC FLUID RETRIEVED. THE PATIENT'S CONDITION IMPROVED AND HE WAS DISCHARGED ON (B)(6) 2010. THE DISLODGED GRAFTMASTER STENT REMAINS FLOATING IN THE LOWER EXTREMITY. THOUGH REQUESTED NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT DISTAL INSTENT RESTENOSIS OF AN UNKNOWN STENT IN THE RCA. THE LESION WAS PREDILATED WITH A 2.0 X 15 NON-ABBOTT BALLOON. AN ATTEMPT WAS MADE TO ADVANCE THE PROMUS STENT DELIVERY SYSTEM (SDS); HOWEVER, IT WOULD NOT CROSS, SO THEY GRABBED A GUIDELINER DEVICE AND ATTEMPTED TO ADVANCE THE PROMUS SDS AGAIN; HOWEVER, IT WOULD NOT EXIT THE GUIDELINER DEVICES. THE SDS WAS THEN REMOVED FROM THE BODY AND IT WAS NOTICED THAT THE STENT WAS PUSHED BACK OFF THE BALLOON. THE CASE WAS SUCCESSFULLY COMPLETED WITH ANOTHER STENT AND THE PATIENT IS FINE. NO ADDITIONAL INFORMATION WAS PROVIDED. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.

    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 0050561

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR DILATATION CATH: 2.0X15 APEXGUIDE WIRE: KINETIX