BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2154532 · Received July 8, 2011

    Report

    Report Number
    2024168-2011-04886
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    March 1, 2011
    Report Date
    June 14, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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. AT THIS POINT A WIRE DISSECTION WAS NOTED IN THE RIGHT POSTERIOR LATERAL AND THE PROCEDURE WAS TERMINATED. THE SUBJECT WAS DISCHARGED ON (B)(6) 2011 AND THE EVENTS AS REPORTED WERE RESOLVED WITH NO RESIDUAL EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED. THE 2.5 X 12 MM PROMUS, THE 3.0 X 15 MM PROMUS, THE 3.5 X 28 MM PROMUS AND THE 3.5 X 12 PROMUS BEING FILED UNDER SEPARATE MEDWATCH MFR NUMBERS. DIL CATH: SCIMED APEX, SCIMED NC QUANTUM APEX. GUIDE WIRE: SCIMED CHOICE EX SUPPORT, CHOICE FLOPPY. INFLATION: ENCORE 26. GUIDE CATH: 6 FR LAUNCHER, SHERPA. RHV: COPILOT. OTHER: PRONTO LP. STENT: PROMUS (3.0X15). (B)(4) - INDICATION FOR USE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THERE WAS NO REPORTED PRODUCT DEFICIENCY. THE REPORTED ANGINA, EMBOLISM, ARRHYTHMIA (INCLUDING BRADYCARDIA), HYPOTENSION AND OCCLUSION ARE LISTED IN THE PROMUS INSTRUCTIONS FOR USE (IFU) AS KNOWN ADVERSE EVENTS ASSOCIATED WITH CORONARY STENTING. IT WAS REPORTED THAT THE PROMUS STENT WAS IMPLANTED FOR TREATMENT OF AN 80% RE-STENOSED PROMUS STENT. IT SHOULD BE NOTED THAT 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 IMPLANTATION OF THE STENT TO TREAT IN-STENT RESTENOSIS DOES NOT APPEAR TO HAVE DIRECTLY CAUSED OR CONTRIBUTED TO THE REPORTED PATIENT EFFECTS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, COULD NOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURING, DESIGN OR LABELING THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT WAS RANDOMIZED INTO THE (B)(4) STUDY ON (B)(6) 2009. THE TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A 90% STENOSIS. THE TARGET LESION WAS TREATED WITH PRE-DILATATION, AND PLACEMENT OF A 2.5 X 12 MM STUDY STENT, AND POST-DILATATION WITH 19% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON (B)(6) 2009 ON ASPIRIN AND CLOPIDOGREL. THE SITE REPORTED AN EVENT OF CARDIAC CHEST PAIN WITH AN ONSET OF (B)(6) 2011. THE SUBJECT WAS HOSPITALIZED ON (B)(6) 2011, 567 DAYS POST INDEX PROCEDURE, AND TREATED WITH REVASCULARIZATION TO THE TARGET VESSEL/TARGET LESION FOR THE TREATMENT OF AN 80% RESTENOSIS OF THE PROMUS STENT WITH A DRUG ELUTING STENT. TREATMENT WAS ALSO PERFORMED ON THE RIGHT CORONARY ARTERY (RCA) A NON TARGET VESSEL, FOR THE TREATMENT OF RESTENOSIS OF PREVIOUSLY PLACED NON-ABBOTT STENTS WITH THE PLACEMENT OF FOUR PROMUS STENTS. THE ATTEMPT TO CROSS WITH THE 3.0 X 15 PROMUS STENT FAILED INITIALLY; HOWEVER, AFTER ADDITIONAL PREDILATATION, WAS ABLE TO CROSS AND BE DEPLOYED. A 3.0 X 28 MM, 3.5 X 28 MM AND 3.5 X 12 MM STENTS WERE DEPLOYED OVERLAPPING THE IN THE RCA. DURING THE TREATMENT OF THE RCA, THE PATIENT WAS EXPERIENCING CHEST PAIN AND ST ELEVATION IN THE INFERIOR LEADS. THE PATIENT WAS TREATED FOR BRADYCARDIA WITH A PACEMAKER. AN INTRA AORTA BALLOON PUMP WAS PLACED AS THE PATIENT WAS MANIFESTING EVIDENCE OF HYPOTENSION. THERE WAS A NO REFLOW DUE TO EXTENSIVE ATHERO-EMBOLIZATION FROM THE STENTING OF THE MID RCA. INTERGRELLIN AND ADENOSINE WERE ADMINISTERED AND FLOW DID NOT IMPROVE.

    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 68 YR Hospitalization| R