BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1172347 · Received September 19, 2008

    Report

    Report Number
    2024168-2008-00827
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 4, 2008
    Report Date
    August 7, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO DETERMINE A CONCLUSIVE ROOT CAUSE FOR THE SHAFT SEPARATION. EVAL SUMMARY: QA ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH BLOOD VISIBLE ON THE HUB, HYPOTUBE, INFLATION LUMEN, BALLOON, AND IN THE GUIDE WIRE LUMEN, IN THE INFLATION LUMEN, AND THE BALLOON. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE SHAFT WAS SEPARATED AT THE GUIDE WIRE EXIT NOTCH. THE MATERIAL AT THE SEPARATION WAS JAGGED AND TORN. THERE WAS A KINK IN THE HYPOTUBE 88.5 CM DISTAL TO THE STRAIN RELIEF TUBING. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO AND ANALYSIS OF THE RETURNED DEVICE. IT WAS REPORTED THAT AFTER THE PROMUS STENT WAS DEPLOYED, THE SHAFT SEPARATED INSIDE THE PT. THE DEVICE WAS REMOVED SUCCESSFULLY WITH NO PT COMPLICATIONS. ANALYSIS OF THE SDS NOTED EVIDENCE OF PREPARATION AND USAGE, AS REPORTED. FURTHER, IT WAS CONFIRMED THAT THE INNER AND OUTER MEMBERS WERE SEPARATED AT THE GUIDE WIRE EXIT NOTCH. THE FRACTURE FACES AT BOTH SEPARATIONS WERE JAGGED AND TORN, WHICH SUGGESTS THAT TENSILE FORCE CONTRIBUTED TO THE SEPARATION. ALTHOUGH NO RESISTANCE WAS REPORTED, FACTORS CAN CONTRIBUTE TO DIFFICULTIES REMOVING THE SDS AFTER DEPLOYING THE STENT IMPLANT INCLUDE, BUT ARE NOT LIMITED TO, LESION CALCIFICATION, INCOMPLETE BALLOON DEFLATION, LEAKS, RUPTURES, OR BALLOON MATERIAL TRAPPED BETWEEN/UNDER THE STENT IMPLANT STRUTS. TO HELP ENSURE THIS TYPE OF DAMAGE IS NOT THE RESULTS OF THE MFG PROCESS, ALL DEVICES ARE SUBJECT TO VISUAL INSPECTIONS AT VARIOUS STEPS DURING THE MFG PROCESS. IN THIS CASE, IT IS NOT KNOWN IF THE LESION WAS CALCIFIED OR TORTUOUS, WHICH WOULD HAVE CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED, AND THEREFORE, A CONCLUSIVE ROOT CAUSE CANNOT BE DETERMINED FOR THE SHAFT SEPARATION. ADDITIONALLY, ONE KINK WAS NOTED IN THE HYPOTUBE, THOUGH IT IS NOT LIKELY THAT IT CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED SINCE IT WAS LOCATED PROXIMAL TO THE GUIDEWIRE EXIT NOTCH. IT IS POSSIBLE THAT THE KINK OCCURRED DURING OR AFTER THE PROCEDURE, AS THE DEVICE WAS PACKAGED AND SHIPPED TO ABBOTT VASCULAR FOR ANALYSIS. A REVIEW OF FINISHED DEVICE LOT HISTORY RECORDS DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT, THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. THIS MDR IS CONSIDERED CLOSED BY THE PRODUCT PERFORMANCE GROUP.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: SHAFT SEPARATION HAS PREVIOUSLY CAUSED OR CONTRIBUTED TO PT INJURY. DEVICE ISSUE: SHAFT SEPARATION. IT WAS REPORTED THAT POST STENT DEPLOYMENT, THE 2.5 X 28 MM PROMUS STENT DELIVERY SYSTEM (SDS) SHAFT, AT THE MONORAIL SEGMENT, FRACTURED INSIDE THE PT; THE CATHETER WAS REMOVED SUCCESSFULLY WITH NO PT COMPLICATIONS. THIS IS BEING REPORTED BASED ON THE RETURNED PRODUCT EVAL THAT REVEALED A SHAFT SEPARATION. YOU ARE RECEIVING THIS MDR FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORP DISTRIBUTES PROMUS AS ITS OWN BRAND LABELLING 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8041461

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK