BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1839617 · Received September 16, 2010

    Report

    Report Number
    2024168-2010-01929
    Event Type
    Injury
    Date Received
    September 16, 2010
    Date of Event
    August 23, 2010
    Report Date
    August 25, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE 2.5 X 18 PROMUS RX (PART# 1009539-18B, LOT/SERIAL# 0042861/(B)(4)) IS BEING FILED UNDER ANOTHER MFR NUMBER. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. A F/U WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE UNITED STATES.

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). EVALUATION SUMMARY: 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. IT WAS REPORTED THE SDS WAS ATTEMPTED TO ADVANCE THROUGH A PREVIOUSLY IMPLANTED STENT, AND ADDITIONALLY, IT WAS REPORTED ATTEMPTS WERE MADE TO PUSH THE SDS FURTHER AS RESISTANCE WAS ENCOUNTERED. IT SHOULD BE NOTED THE PROMUS INSTRUCTIONS FOR USE STATES: "PLACE THE STENT IN THE DISTAL LESION BEFORE THE PROXIMAL LESION IN ORDER TO MINIMIZE DISLODGEMENT RISK INCURRED BY TRAVERSING THROUGH DEPLOYED STENTS." THE IFU ALSO STATES: "APPLYING EXCESSIVE FORCE TO THE DELIVERY SYSTEM CAN POTENTIALLY RESULT IN LOSS OR DAMAGE TO THE STENT AND/OR DELIVERY SYSTEM COMPONENTS." IN THIS CASE, IT IS LIKELY THAT THE STENT DISLODGEMENT IS RELATED TO USE OF THE PRODUCT, AS THERE WAS NO DAMAGE NOTED DURING INSPECTION PRIOR TO USE. INTERACTION WITH THE TORTUOUS AND CALCIFIED LESION/ANATOMY DURING THE ATTEMPT TO CROSS THE PREVIOUSLY IMPLANTED STENT MAY HAVE RESULTED IN AN INTERACTION WITH THE STENT IMPLANT THAT COULD HAVE CAUSED DAMAGE. EXCESSIVE FORCE APPLIED TO THE SDS IN THE ATTEMPT TO PUSH THE SDS FURTHER WOULD HAVE RESULTED IN THE STENT ULTIMATELY DISLODGING. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND THE LOT NUMBER WAS NOT REPORTED; THEREFORE, A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS A FEMALE OVER 18 YEARS OF AGE WITH HIGH GRADE LESIONS IN THE OSTIAL CIRCUMFLEX (CX), OSTIAL LEFT ANTERIOR DESCENDING ARTERY (LAD) AND DISTAL LEFT MAIN (LM). TARGET LESION WAS 70% + STENOSED, ECCENTRIC, DE NOVO WITH A 70 DEGREE BEND. THE PT WAS NOT A CANDIDATE FOR SURGERY. THE LESION WAS PREDILATED WITH A NON-ABBOTT BALLOON DILATATION CATHETER TO 8 ATMS. TWO NON-ABBOTT GUIDE WIRES WERE PLACED DOWN THE LAD AND CX. A 3.5 X 12 PROMUS WAS PLACED IN THE LM, A 2.5 X 18 PROMUS STENT IN THE LAD DISTAL TO THE FIRST. THEY WERE UNABLE TO GET THE STENT TO CROSS THROUGH THE PREVIOUSLY PLACED STENT. IN PULLING THE STENT BACK, THE STENT BECAME DISLODGED FROM THE BALLOON. THEY WERE ABLE TO GET A 2.5 X 12 STENT AND 2.5 X 8 STENT TO COVER UP THE SPIRAL DISSECTION. THEY THEN TACKED THE DISLODGED STENT IN THE LM USING BOTH A 3.5 AND 4.0 NON-ABBOTT BALLOON. THE PHYSICIAN WAS ABLE TO CONFIRM PLACEMENT OF THE DISLODGED STENT IN THE LM THROUGH IVUS. THE PT WAS STABLE POST PROCEDURE AND HAD NO IMPACT FROM THE DISLODGED STENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Female Required Intervention (PART 1009539-18B, LOT/SERIAL 0042861/522514) | DIL CATH: APEX, 2.0 X 20 UNK BALLOON| GUIDE CATH: 8 FRENCH JL4| GUIDE WIRE: 2 CHOICE INTERMEDIATE| OTHER: IVUS| STENT: PROMUS RX | GUIDE CATH: 8 FRENCH JL4| OTHER: IVUS| GUIDE WIRE: 2 CHOICE INTERMEDIATE| DIL CATH: APEX, 2.0 X 20 UNK BALLOON| (PART 1009539-18B, LOT/SERIAL 0042861/(B)(4))| STENT: PROMUS RX