BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 4182997 · Received October 17, 2014

    Report

    Report Number
    2024168-2014-06808
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    February 26, 2014
    Report Date
    September 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. ON (B)(6) 2014, 748 DAYS POST INDEX PROCEDURE, THE 100% THROMBOSED RESTENOSIS OF THE PREVIOUSLY PLACED NON STUDY STENTS (4.5 MM NON-ABBOTT STENT, 4.0 X 12 MM NON-ABBOTT STENT, 3.5 MM X 18 MM PROMUS, 4.00 X 15 MM PROMUS STENT, 4.00 MM X 16 MM NON-ABBOTT STENT, AND 4.00 MM X 12 MM NON-ABBOTT STENT); AND STUDY STENTS LOCATED IN R-PDA (CASS SITE #4) WAS TREATED WITH BALLOON ANGIOPLASTY, WITH 0% RESIDUAL STENOSIS. ADDITIONALLY ON (B)(6) 2014, SUBJECT WAS ALSO DIAGNOSED WITH FRONTAL LOBE CVA. (B)(6) 2014 THE EVENTS WERE CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE SUBJECT WAS DISCHARGED ON THE SAME DAY ON PLAVIX AND ASPIRIN. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS: STENT: 2.5 X 12 MM PROMUS STENTS; 4.5 MM LIBERTE STENT,4.0 X 12 MM SCIMED PROMUS; 4.00 MM X 16MM ION STENT AND 4.00 MM X 12 MM ION STENT. (B)(4). THE STENT REMAINS IN THE VESSEL; THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA, MYOCARDIAL INFARCTION, ISCHEMIA, THROMBOSIS, AND NAUSEA, AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) ARE KNOWN PATIENT EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF CORONARY STENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING AND THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. 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. THE TWO OTHER PROMUS DEVICES ARE BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT RECEIVED A 4.0 X 12 MM PROMUS STENT (B)(6) 2009 CASS #4, POSTERIOR DESCENDING ARTERY (PDA) SAPHENOUS VEIN GRAFT TO THE RIGHT PDA, A 3.5 X 18 MM PROMUS (B)(6) 2010, AND A 4.0 X 15 MM PROMUS (B)(6) 2011. THE INDEX PROCEDURE WAS PERFORMED ON (B)(6) 2012 WITH TREATMENT FOR THE RESTENOSED 4.0 X 12 MM PROMUS STENT IN CASS#4; NON-STUDY STENTS OF 3.5 X 18 MM, 4.0 X 15 MM PROMUS , AND IN CASS#1 A 2.5 X 12 MM PROMUS STENTS. ON (B)(6) 2014, SUBJECT PRESENTED WITH THE SYMPTOMS OF SHORTNESS OF BREATH ASSOCIATED WITH SWEATING, NAUSEA, SUB STERNAL CHEST PAIN RADIATING TOWARDS NECK AND JAW AND WAS HOSPITALIZED ON THE SAME DAY. ON (B)(6) 2014, 748 DAYS POST INDEX PROCEDURE, SUBJECTS CARDIAC ENZYMES WERE FOUND TO BE ELEVATED AND SITE REPORTED AN EVENT OF MYOCARDIAL INFARCTION (MI) AND THE SUBJECT WAS HOSPITALIZED ON THE SAME DAY (PEAK CK-MB-49.4 NG/ML, ULN-3.5 NG/ML; PEAK TROPONIN I-20 NG/ML, ULN-0.5 NG.ML). IT WAS OBSERVED THAT THE SUBJECT EXPERIENCED ISCHEMIC SYMPTOMS. ON (B)(6) 2014, CORONARY ANGIOGRAPHY REVEALED: LEFT MAIN CORONARY ARTERY (LMCA) FREE OF DISEASE; LEFT ANTERIOR DESCENDING (LAD) LUMINAL IRREGULARITIES; 1ST DIAGONAL-MILD PROXIMAL DISEASE; 2ND DIAGONAL-NO OBSTRUCTIVE DISEASE; CIRCUMFLEX (LCX) 30% MID STENOSIS; 1ST OBTUSE MARGINAL (OM) MODERATE PROXIMAL DISEASE; RIGHT CORONARY ARTERY (RCA) OCCLUSION, SAPHENOUS VEIN GRAFT (SVG TO OM) OCCLUDED; SVG TO POSTERIOR DESCENDING ARTERY (PDA) (TARGET VESSEL): TOTAL OSTIAL OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    661847 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 0061861

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R