BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1932259 · Received December 17, 2010

    Report

    Report Number
    2024168-2010-02804
    Event Type
    Malfunction
    Date Received
    December 17, 2010
    Date of Event
    November 24, 2010
    Report Date
    November 24, 2010
    Manufacturer
    AV-CLONMEL
    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. DILATATION CATHETER: 3.0 X 15 MM LACROSS; GUIDE WIRE: RINATO; GUIDE CATH: 6F KAMINO JR3.5. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE DEVICE HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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. DAMAGE TO THE PROXIMAL END OF THE STENT IS MOST CONSISTENT WITH THAT OF WHICH OCCURS AS A RESULT OF AN INTERACTION BETWEEN THE MOUNTED STENT AND THE ANATOMY AND/OR THE TIP OF THE GUIDING CATHETER DURING RETRACTION OF THE DEVICE. THE PATIENT ANATOMY WAS HEAVILY TORTUOUS AND REQUIRED MULTIPLE PRE-DILATATIONS, WHICH SUGGESTS THE ANATOMY WAS DIFFICULT AND LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT AS THE SDS WAS RETRACTED AFTER THE FIRST FAILED ATTEMPT TO CROSS THE LESION, THE STENT STRUTS INTERACTED WITH THE ANATOMY AND/OR TIP OF THE GUIDING CATHETER, CONTRIBUTING TO THE STENT DAMAGE AND REPORTED RESISTANCE, AS THERE WAS NO DAMAGE NOTED TO THE STENT DELIVERY SYSTEM (SDS) DURING THE INSPECTION PRIOR TO USE. IT WAS REPORTED THE PROMUS SDS WAS RE-INSERTED INTO THE PATIENT ANATOMY AFTER THE FIRST FAILED ATTEMPT TO CROSS. IT SHOULD BE NOTED THE PROMUS INSTRUCTIONS FOR USE (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 OR/AND DISLODGED FROM THE BALLOON WHEN RETRACTING THE UNDEPLOYED STENT BACK INTO THE GUIDING CATHETER. ADDITIONALLY, THE IFU STATES THAT SHOULD ANY RESISTANCE BE FELT AT ANY TIME DURING EITHER LESION ACCESS OR REMOVAL OF THE DELIVERY SYSTEM POST-STENT IMPLANTATION; REMOVE THE ENTIRE SYSTEM AS A SINGLE UNIT. APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE REPORTED FAILURE TO ADVANCE, DIFFICULTY REMOVING THE SDS, AND STENT DAMAGE APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULT OF A MANUFACTURING DEFICIENCY, DURING MANUFACTURING, ALL SDS ARE 100% CHECKED FOR STENT DAMAGE AND CRIMPED STENT PROFILE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRE-DILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON CATHETER THREE CONSECUTIVE TIMES AT 8 ATMOSPHERES (ATM). THE PROMUS STENT DELIVERY SYSTEM (SDS) EXPERIENCED RESISTANCE AND EVEN WITH FORCE WAS NOT ABLE TO CROSS THE LESION. ADDITIONAL PRE-DILATATION WAS PERFORMED 4 CONSECUTIVE TIMES AT 12 ATM. THE PROMUS SDS WAS ADVANCED AGAIN, BUT WAS STILL UNABLE TO CROSS THE LESION. UPON WITHDRAWAL, SLIGHT RESISTANCE WAS FELT AT THE TIP OF THE GUIDE CATHETER. ONCE OUTSIDE THE PATIENT, THE DEVICE WAS EXAMINED AND THE PROXIMAL END OF THE STENT WAS OBSERVED TO BE DAMAGED. THERE WERE NO REPORTED PATIENT EFFECTS. 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-CLONMEL 0052241

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR