BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1488528 · Received September 29, 2009

    Report

    Report Number
    2024168-2009-01728
    Event Type
    Injury
    Date Received
    September 29, 2009
    Date of Event
    August 24, 2009
    Report Date
    September 4, 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
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANGINA AND THROMBOSIS, AS NOTED IN THE PROMUS IFU, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. THESE KNOWN PATIENT EFFECTS ARE NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. SINCE THERE WAS NO REPORTED PRODUCT MALFUNCTION, THERE DOES NOT APPEAR TO BE ANY INDICATIONS OF A SDS QUALITY DEFICIENCY. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCTS, IF ANY, CANNOT BE DETERMINED, THERE DOES NOT APPEAR TO BE AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. THE SECOND PROMUS (PART 1009541-28B, LOT 8121761), IS BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - MEDICAL INTERVENTION. REPORTING RATIONALE: THROMBOSIS REQUIRING MEDICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE INITIAL STENTING PROCEDURE WAS IN 2009. FOLLOWING PRE-DILATATION, A 2.5 X 18 PROMUS STENT WAS DEPLOYED IN THE MID RCA. A SECOND 2.5X18 PROMUS WAS ADVANCED, BUT REMOVED WITH THE STENT INTACT. A 3.0 X 28 PROMUS STENT WAS THEN DEPLOYED IN THE MID RCA. ONE WEEK LATER, THE PATIENT RETURNED (WITH CHEST PAINS) WITH A TOTAL OCCLUSION (THROMBOSIS) OF THE RCA. TWO STENTS FROM ANOTHER COMPANY WERE IMPLANTED, ONE IN THE DISTAL RCA AND ONE IN THE MID RCA. ANOTHER COMPANY'S THROMBECTOMY DEVICE WAS ALSO USED. 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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R SHEATH: AVANTI 6F, 5F| STENT: PROMUS (PART 1009541-28B, LOT 8121761)| GUIDE WIRE: CHOICE, WHISPER, MIRACLEBROS| DILATATION CATHETER: MAVERICK (X3)| GUIDE CATH: 4F AL, 5F AL