BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 2853544 · Received December 3, 2012

    Report

    Report Number
    2024168-2012-07615
    Event Type
    Injury
    Date Received
    December 3, 2012
    Date of Event
    October 21, 2012
    Report Date
    November 6, 2012
    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. THE LESION WAS PRE-DILATED WITH A 3 MM NON-ABBOTT BALLOON; FOLLOWING PRE-DILATION AGAIN THROMBECTOMY WAS PERFORMED. THE LESION WAS THEN TREATED WITH PLACEMENT OF 3.0 X 32 MM PROMUS STENT COVERING THE ENTIRE PREVIOUSLY DEPLOYED NON-ABBOTT STENT. FOLLOWING STENT DEPLOYMENT THERE WAS EVIDENCE OF SOME DISTAL EMBOLIZATION NOTED INTO THE DOWNSTREAM PORTION OF THE DIAGONAL FILLING THE BODY OF THE DIAGONAL BRISKLY. THIS WAS TREATED WITH POST-DILATATION, USING A 4 MM NON-ABBOTT BALLOON; RESULTING RESIDUAL STENOSIS WAS 0% AND TIMI 3 FLOW WAS NOTED. ON (B)(6) 2012, THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE EVALUATION: THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF EMBOLISM AS LISTED IN THE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN ADVERSE EVENT 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. YOU ARE RECEIVING THIS MDR REPORT FROM (B)(4) DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INDEX PROCEDURE ON (B)(6) 2010 WAS AN OSTIAL LESION LOCATED IN THE LEFT MAIN CORONARY ARTERY (LMCA) WITH 99% STENOSIS AND THE SUBJECT WAS TREATED WITH PREDILATATION AND A 3.0 X 12 MM NON-ABBOTT STENT FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS LESS THAN 5%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND PRASUGREL. ON (B)(6) 2011 THE SUBJECT HAD WORSENING CORONARY ARTERY DISEASE AND TARGET VESSEL REVASCULARIZATION OF NON-ABBOTT DEVICES. ON (B)(6) 2012, 916 DAYS POST INDEX PROCEDURE THE SUBJECT PRESENTED WITH MIDSTERNAL CHEST PAIN RADIATING TO THE SHOULDER WITH SHORTNESS OF BREATH AND NAUSEA; THE SUBJECT WAS HOSPITALIZED THE SAME DAY. CARDIAC ENZYMES WERE ELEVATED AND THE SUBJECT WAS DIAGNOSED WITH NON-ST ELEVATED MYOCARDIAL INFARCTION AND CARDIAC CATHETERIZATION WAS RECOMMENDED. CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED THE TARGET VESSEL (LMCA) STENT WAS WIDELY PATIENT; THE LEFT ANTERIOR DESCENDING ARTERY (LAD) TOTALLY OCCLUDED, DIAGONAL BRANCH PROXIMALLY OCCLUDED; CIRCUMFLEX (LCX) 95-99% NARROWING, OCCLUDED IN THE MID PORTION; RIGHT CORONARY ARTERY (RCA) OCCLUDED IN THE MID PORTION; LEFT INTERNAL MAMMARY (LIMA) TO THE LAD PATIENT WITH 50% NARROWING JUST BEYOND THE ANATOMOSIS; SAPHENOUS VEIN GRAFT (SVG) TO THE DIAGONAL BRANCH PROXIMALLY OCCLUDED IN THE AREA OF THE PREVIOUS NON-ABBOTT STENT; SVG TO RCA OCCLUDED AT THE AORTA. THE PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE WAS TREATED WITH ASPIRATION THROMBECTOMY. FOLLOWING THE THROMBECTOMY THERE WAS A FAIR AMOUNT OF THROMBUS NOTED THROUGH THE NON-ABBOTT STENT AS WELL AS DISTAL TO THE NON-ABBOTT STENT.

    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 52 YR Hospitalization| R