BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS ELEMENT? PLUS

    MDR report key: 4110746 · Received September 23, 2014

    Report

    Report Number
    2134265-2014-05735
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 27, 2014
    Report Date
    September 1, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RETURNED FOR EVALUATION. 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

    SAME CASE AS MDR ID: 2134265-2014-05782. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT STENT RESTENOSIS OCCURRED AND SILENT ISCHEMIA WAS EXPERIENCED. IN (B)(6) 2013, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT'S QUALIFYING CONDITION WAS SILENT ISCHEMIA. ABNORMAL STRESS TEST OR IMAGING STRESS TEST INDICATED ISCHEMIA PRIOR TO PROCEDURE AND THE SUBJECT WAS REFERRED FOR ELECTIVE CARDIAC CATHETERIZATION WHICH REVEALED 3 TARGET LESIONS. TARGET LESION #1 WAS LOCATED IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH 82% STENOSIS AND WAS 18 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. TARGET LESION #1 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 20 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #2 WAS LOCATED IN THE PROXIMAL LAD WITH 71% STENOSIS AND WAS 25 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.4 MM. TARGET LESION #2 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.50 X 28 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION #3 WAS LOCATED IN 1ST OBTUSE MARGINAL (OM) WITH 76% STENOSIS AND WAS 24 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.6 MM. TARGET LESION #3 WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 X 28 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. THE FOLLOWING DAY, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY. IN (B)(6) 2014, THE PATIENT WAS ADMITTED DUE TO SILENT ISCHEMIA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE FOLLOWING DAY, THE 89% IN STENT RESTENOSIS OF THE STUDY STENT LOCATED IN THE DISTAL LAD WAS TREATED WITH BALLOON ANGIOPLASTY WITH 2% RESIDUAL STENOSIS AND TIMI 3 FLOW. THE 77% DE NOVO STENOSIS LOCATED IN THE PROXIMAL LAD WAS TREATED WITH BALLOON ANGIOPLASTY AND PLACEMENT OF A 3.5 X 16 MM PROMUS PREMIER DRUG ELUTING STENT WITH 0% RESIDUAL STENOSIS AND TIMI 3 FLOW. IN ADDITION, THE 86% STENOSIS LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX (LCX) EXTENDING TO 1ST OM WAS TREATED WITH BALLOON ANGIOPLASTY. POST TREATMENT, 49% RESIDUAL STENOSIS AND TIMI 3 FLOW WAS NOTED. SUBSEQUENTLY, THE 86% STENOSIS LOCATED IN THE PROXIMAL LCX EXTENDING TO 1ST OM WAS TREATED WITH BALLOON ANGIOPLASTY USING 3 X 14 MM NON BSC DRUG ELUTING BALLOON WHICH RESULTED IN SLOWING OF FLOW IN THE MARGINAL BRANCH. THIS SLOWING OF THE FLOW WAS TREATED WITH KISSING BALLOON ANGIOPLASTY. A 2.25 X 16 MM PROMUS PREMIER DRUG ELUTING STENT WAS ATTEMPTED TO TREAT THE CIRCUMFLEX ARTERY. HOWEVER DUE TO THE SMALL CALIBRE OF THE ARTERY THE IMPLANTATION FAILED. A DAY AFTER, THE PATIENT WAS DISCHARGED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT IN (B)(6) 2014, FOLLOW-UP CORE LAB ANGIOGRAPHIC FINDINGS OF DISTAL LEFT ANTERIOR DESCENDING (LAD) NOTED ABSENCE OF THROMBUS, ANEURYSM. CORE LAB ALSO REVEALED IN-STENT RESTENOSIS (ISR) STENOSIS PATTERN 1C. TARGET LESION REVASCULARIZATION WAS PERFORMED. FOLLOW-UP CORE LAB ANGIOGRAPHIC FINDINGS OF PROXIMAL LAD NOTED ABSENCE OF THROMBUS, ANEURYSM AND ISR. REMOTE TARGET VESSEL REVASCULARIZATION (TVR) WAS PERFORMED. IN ADDITION POST INDEX PROCEDURE CORE LAB ANGIOGRAPHIC FINDINGS OF PROXIMAL LAD IN (B)(6) 2013 NOTED 30% BRANCH STENOSIS IN 1ST SEPTAL. FOLLOW UP ANGIOGRAPHIC FINDINGS PROXIMAL LAD, NOTED 70% BRANCH STENOSIS. FOLLOW-UP CORE LAB ANGIOGRAPHIC FINDINGS OF 1ST OM, NOTED ABSENCE OF THROMBUS, ANEURYSM. CORE LAB ALSO REVEALED ISR STENOSIS PATTERN 1C. TARGET LESION REVASCULARIZATION AND REMOTE TVR WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590802 PROMUS ELEMENT? PLUS STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493911420220 15590154

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R