BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT¿ PLUS

    MDR report key: 3052115 · Received April 11, 2013

    Report

    Report Number
    2134265-2013-02637
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 15, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RECEIVED FOR ANALYSIS AS IT WAS IMPLANTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE SUBJECT PRESENTED WITH SOB SECONDARY TO FLUID OVERLOAD DUE TO ACUTE EXACERBATION OF SYSTOLIC CONGESTIVE HEART FAILURE AND END STAGE RENAL DISEASE AND WAS ADMITTED TO THE HOSPITAL FOR EMERGENCY DIALYSIS. THE PATIENT HAD MISSED DIALYSIS EARLIER IN THE WEEK. THE SUBJECT ALSO PRESENTED WITH STABLE ANGINA (CCS CLASS-4) AND HAD A POSITIVE NUCLEAR TEST WHICH DEMONSTRATED A LARGE ANTERIOR WALL DEFECT AND THE SUBJECT WAS SCHEDULE FOR CARDIAC CATHETERIZATION ON THE FOLLOWING DAY. THE NEXT DAY DURING PTCA OF THE SVG, THE SUBJECT HAD FLASH PULMONARY EDEMA WHILE ON THE CATHETERIZATION TABLE AND ALSO DEVELOPED WORSENING CHEST PAIN AND SHORTNESS OF BREATH DUE TO WHICH THE PROCEDURE WAS TERMINATED EARLY AND THE SUBJECT AGAIN UNDERWENT HEMODIALYSIS. THE SUBJECT WAS RE-SCHEDULED FOR REPEAT INTERVENTION THE FOLLOWING DAY. (THE SITE HAS BEEN RE-QUERIED FOR CONFIRMING THE DATE OF INTERVENTION). THE FOLLOWING DAY THE 70% TO 80% STENOSIS LOCATED AT THE OSTIAL PORTION OF THE SVG TO R-PDA WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 4 X 16 MM PROMUS STENT WITH 0% RESIDUAL STENOSIS. ALSO, THE 90% STENOSIS LOCATED AT THE OSTIAL PORTION OF THE SVG TO LCX WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 4 X 16 MM PROMUS STENT WITH 0% RESIDUAL STENOSIS. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT POST A CORONARY STENTING TREATMENT PROCEDURE, A RESTENOSIS OCCURRED. IN (B)(6) 2013, THE PATIENT PRESENTED WITH CORONARY ARTERY DISEASE (CAD) AND WAS REFERRED FOR TARGET VESSEL REVASCULARIZATION. TARGET LESION # 1 WAS A DE NOVO LESION LOCATED IN THE SAPHENOUS VEIN GRAFT TO LEFT POSTERIOR DESCENDING ARTERY (SVG TO L-PDA) WITH 70% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 4 MM. TARGET LESION #1 WAS TREATED WITH DIRECT STENT PLACEMENT USING A 4 X 16 MM PROMUS ELEMENT PLUS STENT. FOLLOWING POST DILATION, RESIDUAL STENOSIS WAS 0%. THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2013, THE SUBJECT PRESENTED DUE TO CAD AND WAS HOSPITALIZED ON THE SAME DAY. PCI WAS PERFORMED IN SVG TO L-PDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155423 PROMUS ELEMENT¿ PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493911416400 15193272

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention