BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ION?

    MDR report key: 4002201 · Received August 12, 2014

    Report

    Report Number
    2134265-2014-04662
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    NIQ
    PMA / PMN Number
    P100023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR.: THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. 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).

    Description of Event or Problem · 1

    (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT WORSENING CORONARY ARTERY DISEASE OCCURRED. IN (B)(6) 2012, THE PATIENT PRESENTED DUE TO STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, INDEX PROCEDURE WAS PERFORMED. THE TARGET LESION WAS AN IN-STENT RESTENOTIC LESION, OF AN UNSPECIFIED DRUG ELUTING STENT (DES), LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY EXTENDING TO DISTAL LAD WITH 100% STENOSIS AND WAS 45 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.50 MM X 16 MM ION¿ STENT. FOLLOWING POST-DILATATION, RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN ON THE SAME DAY. IN (B)(6) 2014, THE PATIENT PRESENTED DUE TO WORSENING CORONARY ARTERY DISEASE. PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS ATTEMPTED TO THE TARGET LESION AND IN THE FIRST DIAGONAL BRANCH IN ORDER TO TREAT THE EVENT. HOWEVER, THE ATTEMPT WAS UNSUCCESSFUL. THE EVENT WAS CONSIDERED NOT RECOVERED/NOT RESOLVED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT DURING THE TIME OF THE EVENT, CORONARY ANGIOGRAPHY WAS PERFORMED AND REVEALED FLUSH OCCLUSION OF THE PREVIOUSLY PLACED STUDY STENT IN MID LEFT ANTERIOR DESCENDING (LAD) ARTERY.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PRIOR TO THE INDEX PROCEDURE ((B)(6) 2011) THE PATIENT HAD ANGIOGRAPHY PERFORMED AND REVEALED AN OCCLUSION OF A PREVIOUSLY PLACED UNKNOWN STENT IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY INDEX PROCEDURE, ANGIOPLASTY WAS ATTEMPTED TO TREAT THE OCCLUSION LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY, AS WELL AS A 20% PROXIMAL RESTENOSIS OF A PREVIOUSLY PLACE UNKNOWN STENT IN THE DIAGONAL. ANGIOPLASTY WAS ATTEMPTED TO TREAT THE MID LAD OCCLUSION; HOWEVER, IT WAS UNSUCCESSFUL AFTER A PT2 GUIDE WIRE FAILED TO CROSS THE LESION. IT WAS FURTHER REPORTED POST INDEX PROCEDURE ((B)(6) 2012) THE PATIENT WAS ALSO DISCHARGED ON PRASUGREL. AT THE TIME OF THE EVENT ((B)(6) 2014), THE PATIENT PRESENTED DUE TO DYSPNEA ON EXERTION AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE CORONARY ANGIOGRAPHY REVEALED 100% STENT THROMBOSIS OF THE PREVIOUSLY PLACED STUDY STENT LOCATED IN THE MID LAD ARTERY. AN ATTEMPT WAS MADE TO TREAT THE OCCLUSION WITH BALLOON ANGIOPLASTY, HOWEVER, IT WAS UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    480173 ION? CORONARY DRUG-ELUTING STENT NIQ BOSTON SCIENTIFIC - MAPLE GROVE H7493902316250 14432214

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention