BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1348678 · Received March 20, 2009

    Report

    Report Number
    2024168-2009-00453
    Event Type
    Injury
    Date Received
    March 20, 2009
    Date of Event
    February 23, 2009
    Report Date
    February 24, 2009
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVALUATION AT THE TIME OF THIS REPORT. EVALUATION SUMMARY: QUALITY ASSURANCE ANALYSIS REVEALED THAT THE STENT DELIVERY SYSTEM (SDS) WAS RETURNED WITH NO BLOOD VISIBLE. THERE WAS CONTRAST VISIBLE IN THE INFLATION LUMEN. THE STENT IMPLANT WAS STATIONARY ON THE BALLOON AND BETWEEN THE MARKERS. THERE WERE FIVE STRETCHED STRUTS IN THE FIRST ROW AT THE DISTAL END OF THE STENT IMPLANT. THERE WAS ONE FLARED STRUT IN THE SECOND ROW AT THE DISTAL END OF THE STENT IMPLANT. THERE WAS NO OTHER DAMAGE NOTED TO THE STENT IMPLANT. THE BALLOON WAS TIGHTLY FOLDED. THERE WERE NO KINKS OR DAMAGE NOTED TO THE TIP AND INNER MEMBER. THERE WAS NO OTHER DAMAGE NOTED TO THE SDS. THE TIP SEAL LENGTH WAS MEASURED AND MET MANUFACTURING CRITERIA. A SNAP GAUGE WAS USED TO MEASURE THE OUTER DIAMETER OF THE STENT IMPLANT PROXIMAL TO THE DAMAGE. THE STENT IMPLANT OUTER DIAMETER MEASUREMENTS MET MANUFACTURING CRITERIA. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVALUATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: DISSECTION REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE TARGET LESION WAS THE OM. AFTER PRE-DILATATION, AN ATTEMPT WAS MADE TO CROSS WITH THE 2.5 X 18 MM PROMUS 2.5X18, BUT IT WOULD NOT CROSS. ANOTHER PRE-DILATION WAS PERFORMED AND A SECOND ATTEMPT WAS MADE TO CROSS WITH THE SAME PROMUS, BUT IT WAS UNSUCCESSFUL. THE DEVICE WAS REMOVED AND IT WAS NOTED THAT THE STENT STRUT WAS BENT ON THE DISTAL END. AT THIS TIME, A SMALL DISSECTION WAS OBSERVED AND WAS SUCCESSFULLY TREATED WITH A 3.0 X 8 MM PROMUS. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. 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 NIQ ABBOTT VASCULAR-CARDIAC THERAPIES NA 8111261

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention DILATION CATHETER: 1.5 X 20 MM APEX| STENT: 2.5 X 18 MM PROMUS (8093061)| QUANTUM MAVERICK| 2.0 X 15 MM| 2.5 X 12 MM