BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2834336 · Received November 15, 2012

    Report

    Report Number
    2024168-2012-07221
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED PATIENT EFFECT OF ANGINA AND HOSPITALIZATION ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS A KNOWN ADVERSE PATIENT EVENT. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF ANGINA AND RESTENOSIS ARE LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM, (IFU) AS KNOWN ADVERSE EVENTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS 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.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED STATES, THE SUBJECT UNDERWENT A TARGET VESSEL REVASCULARIZATION (TVR) WITH PLACEMENT OF A DRUG ELUTING STENT TO THE DISTAL RIGHT CORONARY ARTERY (RCA), RESULTING IN REDUCTION OF THE PRE-TREATMENT DIAMETER STENOSIS FROM 75% TO 0 %. THE SUBJECT ALSO UNDERWENT A NON-TVR TO THE RIGHT PROXIMAL POSTERIOR ANTERIOR VESSEL (R-PAV). ON (B)(6) 2012 THE EVENT RESOLVED WITHOUT RESIDUAL EFFECTS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2012. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE WAS (B)(6) 2009 WITH PLACEMENT OF A 3.0 X 28 MM PROMUS STENT IN THE 75% STENOSED, DISTAL RIGHT CORONARY ARTERY (RCA) WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2012 THE SITE REPORTED THE ONSET EVENT OF ANGINA PECTORIS AND THE SUBJECT WAS HOSPITALIZED THE SAME DAY, 1224 DAYS POST INDEX PROCEDURE. THE SUBJECT HAS NOT RECOVERED AND THE EVENT HAS NOT RESOLVED AT THE TIME OF THIS REPORT. THERE WAS NO REPORT OF THE TREATMENT PROVIDED. NO OTHER ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 8100761

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R