BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3090546 · Received May 2, 2013

    Report

    Report Number
    2024168-2013-02726
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 13, 2013
    Report Date
    April 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS ATTEMPTED TO TREAT THE SVG GRAFT TO 2ND OM USING A 2.50 X 40 MM AND A 2.50 X 15 MM UNSPECIFIED BALLOON, HOWEVER, AFTER BALLOON ANGIOPLASTY THE STENOSIS REMAINED 100% IN THE 15 YEAR GRAFT; NO FURTHER INTERVENTION WAS PERFORMED. ADDITIONALLY, THE TOTALLY OCCLUDED MID PORTION OF THE 2ND OM WAS BALLOONED USING A 2.0 X 8 MM BALLOON 2-3 TIMES. THIS STENOSIS WAS OPENED AND COLLATERALS WERE PROVIDED TO THE DISTAL 3RD OM WHICH WAS VERY SMALL AND DIFFUSELY DISEASED UP TO 80-90%. NO FURTHER INTERVENTION WAS PERFORMED. ON (B)(6) 2013, THE SUBJECT WAS DISCHARGED. ON (B)(6) 2013, 939 DAYS POST INDEX PROCEDURE, THE SUBJECT WAS DIAGNOSED WITH ANGINA AND WAS HOSPITALIZED. CARDIAC CATHETERIZATION REVEALED A 90-95% HIGH GRADE STENOSIS IN THE PROXIMAL CIRCUMFLEX AND WAS TREATED WITH PRE-DILATATION USING A 2.50 X 15 MM BALLOON. REPEAT ANGIOGRAPHY REVEALED LONG AREAS OF CONTINUED RECOIL AND STENOSIS. THIS WAS TREATED WITH PLACEMENT OF TWO OVERLAPPING 2.50 X 38 MM AND 2.50 X 24 MM NON-ABBOTT STENTS; POST-DILATATION RESIDUAL STENOSIS WAS 0%. ON (B)(6) 2013, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED. NO ADDITIONAL INFORMATION WAS PROVIDED. INCORRECT ANATOMY. IN THIS CASE, THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, OCCLUSION, AND THROMBOSIS, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING PROCEDURES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. IT WAS REPORTED THAT AN ATTEMPT WAS MADE TO TREAT THE SAPHENOUS VEIN GRAFT (SVG) GRAFT TO 2ND OBTUSE MARGINAL (OM). IT SHOULD BE NOTED THAT THE IFU STATES: THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM (PROMUS STENT) IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    THIS EVENT WAS REPORTED FROM A BOSTON SCIENTIFIC CLINICAL TRIAL AND THERE IS SOME DISCREPANCY REGARDING THE IDENTIFICATION OF THE DEVICE. ON (B)(6) 2012 AS A PROGRESSION OF THE CORONARY ARTERY DISEASE/TARGET VESSEL REVASCULARIZATION, THE SUBJECT HAD A 2.50 X 24 MM PROMUS STENT PLACED TO THE SAPHENOUS VEIN GRAFT (SVG) TO THE 2ND OM (OM2). ON (B)(6) 2013, 926 DAYS POST INDEX PROCEDURE, THE SUBJECT PRESENTED WITH MID STERNAL CHEST PAIN RADIATING DOWN THE NECK TO THE LEFT ARM. THE ECHOCARDIOGRAM (ECG/EKG) PERFORMED REVEALED SOME ST CHANGES IN V3 THROUGH V6. TROPONIN VALUES NOTED TO BE ELEVATED. THE SUBJECT WAS DIAGNOSED WITH MYOCARDIAL INFARCTION AND WAS HOSPITALIZED. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED: 20%; LEFT ANTERIOR DESCENDING (LAD) ARTERY: TOTALLY OCCLUDED IN THE MID PORTION AFTER A SMALL DIAGONAL WHICH HAD 30-40% IRREGULARITIES; CIRCUMFLEX (LCX) (TARGET VESSEL): 2ND OM IS TOTALLY OCCLUDED IN MID PORTION AFTER GIVING OFF A BRANCH AND APPEARED THERE MAY BE A LITTLE THROMBUS, CONTINUING IN THE ATRIOVENTRICULAR (AV) GROOVE, WAS SMALL AND WITH 30% IRREGULARITIES; RIGHT CORONARY ARTERY (RCA): 50% STENOSIS IN MID AND DISTAL PORTION; 40-50% STENOSIS IN RIGHT POSTERIOR DESCENDING ARTERY (R-PDA); 30-40% DIFFUSE STENOSIS IN RIGHT POSTERIOR LATERAL (RPL); SVG GRAFT TO 2ND OM: TOTALLY OCCLUDED IN THE MID PORTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192972 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R| S