BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1464438 · Received September 4, 2009

    Report

    Report Number
    2024168-2009-01612
    Event Type
    Injury
    Date Received
    September 4, 2009
    Date of Event
    July 30, 2009
    Report Date
    August 14, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    STENOSIS AND ANGINA, AS NOTED IN THE PROMUS IFU, ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IN THIS CAUSE, IT IS POSSIBLE THAT THE ANGINA WAS A SECONDARY EFFECT OF THE STENOSIS, WHICH REQUIRED HOSPITALIZATION AND TREATMENT WITH CABG SURGERY. 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 TWO OTHER PROMUS STENTS, 3.0 X 23 PROMUS (PART 1009541-23B, LOT 8112561), 3.0 X 18 MM PROMUS (PART 1009541-18B, LOT UNK). ARE BEING FILED UNDER THE SAME MFR#.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - SURGICAL INTERVENTION/PERMANENT DAMAGE. REPORTING RATIONALE: RESTENOSIS REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT IN 2008, ANOTHER COMPANY'S STENT WAS IMPLANTED IN THE MID LAD. THE FOLLOWING MONTH, THE PATIENT RETURNED FOR FOLLOW-UP AND WAS ASYMPTOMATIC. ANGIOGRAPHY WAS PERFORMED REVEALING RESTENOSIS IN THE STENT, AND A MORE DISTAL DE NOVO LESION. THE DISTAL LESION WAS PRE-DILATED AND A 2.5 X 18 PROMUS STENT WAS IMPLANTED, A 3.0 X 23 PROMUS STENT WAS IMPLANTED INSIDE THE OTHER COMPANY'S STENT, AND A 3.0 X 18 PROMUS STENT WAS DEPLOYED SLIGHTLY PROXIMAL WITH A 1 MM OVERLAP. FOURTEEN DAYS LATER, THE PATIENT UNDERWENT CARDIAC CATHETERIZATION DUE TO RECURRENT ANGINA AND AN ABNORMAL STRESS TEST. THE ANGIOGRAPHY FOLLOWED BY IVUS REVEALED 50% OSTIAL STENOSIS IN THE LAD, 75% OSTIAL STENOSIS, 80% PROXIMAL STENOSIS, 90% IN-STENT RESTENOSIS IN MIDPORTION OF THE FIRST STENT, AND 80% IN-STENT RESTENOSIS OF THE DISTAL STENT. THE NEXT DAY, THE PATIENT UNDERWENT CABG SURGERY WITH A LIMA TO THE LAD PAST THE STENTS. THE PATIENT WAS DISCHARGED THE FOLLOWING MONTH, WITH ASPIRIN AND CLOPIDOGREL. 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 8121641

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R| S 3.0 X 18 MM PROMUS (PART 1009541-18B| LOT 8112561)| STENT: TAXUS| DILATATION CATHETER: 2.0 X 20 VOYAGER