BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 1961920 · Received January 14, 2011

    Report

    Report Number
    2024168-2011-00338
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    August 13, 2010
    Report Date
    December 20, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. (B)(4): INDICATION FOR USE. THERE WAS NO REPORTED PRODUCT DEFICIENCY. ANGINA AND RESTENOSIS ARE KNOWN ADVERSE EVENTS AS LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU). ADDITIONALLY, ANGINA, RESTENOSIS, SURGICAL PROCEDURE, AND HOSPITALIZATION ARE LISTED IN THE RISK ASSESSMENT MATRIX AS NO-FAULT COMPLICATIONS. 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. SINCE IT WAS REPORTED THAT THE PROMUS STENT WAS IMPLANTED TO TREAT RESTENOSIS OF A PREVIOUSLY IMPLANTED BARE METAL STENT, IT SHOULD BE NOTED THAT THE PROMUS 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 (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH REFERENCE VESSEL DIAMETERS OF 2.5 MM TO 4.25 MM. THE IFU CAUTIONS THAT: THE SAFETY AND EFFECTIVENESS OF THE PROMUS STENT HAVE NOT BEEN ESTABLISHED FOR SUBJECT POPULATIONS WITH IN-STENT RESTENOSIS. IN THIS CASE, IT CANNOT BE DETERMINED WHETHER THE IFU DEVIATION CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA TRIAL THAT ON (B)(6) 2010, THE PATIENT UNDERWENT DEPLOYMENT OF THE PROMUS 4.0 X 18 MM STENT TO THE MID RIGHT CORONARY ARTERY (MRCA) TO TREAT A 95% IN-STENT RESTENOSIS OF A PREVIOUSLY PLACED BARE METAL STENT. POST PROCEDURE RESIDUAL STENOSIS WAS 0% AND TIMI III FLOW. THE PATIENT WAS DISCHARGED FROM THE HOSPITALIZATION ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CARDIAC CHEST PAIN. THE PATIENT WAS REPORTEDLY SYMPTOM FREE FOR TWO WEEKS AFTER THE INDEX PROCEDURE, AND THEN STARTED EXPERIENCING PROGRESSIVE EXERTIONAL CHEST PAIN. A CARDIAC CATHETERIZATION PERFORMED ON (B)(6) 2010 REVEALED RE-STENOSIS OF THE PRE-EXISTING STENTS AND PROGRESSIVE OF HIS NATIVE VESSEL CORONARY ARTERY DISEASE. THE RCA REVEALED A DISTAL 60% TUBULAR STENOSIS. ON (B)(6) 2010, A CORONARY ARTERY BYPASS GRAFT (CABG) PROCEDURE WAS PERFORMED WITH A SAPHENOUS VEIN GRAFT USED TO BYPASS THE RCA. POST PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE ICU. THE PATIENT WAS DISCHARGED HOME OF (B)(6) 2010. THE CARDIAC CHEST PAIN WAS REPORTED AS CONTINUING AND THE PATIENT IS RECOVERING. IN THE OPINION OF THE PHYSICIAN, THE CARDIAC CHEST PAIN WAS CONSIDERED SEVERE IN INTENSITY, NOT RELATED TO THE STUDY DRUG, POSSIBLY RELATED TO THE STUDY DEVICE, AND UNLIKELY RELATED TO THE STUDY PROCEDURE. THOUGH REQUESTED, NO 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

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| S