BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3023051 · Received March 27, 2013

    Report

    Report Number
    9612164-2013-00337
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 28, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE - (STENT THROMBOSIS). (NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED) - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. EVALUATION CONCLUSIONS: INHERENT RISK OF PROCEDURE - (STENT THROMBOSIS). (B)(4).

    Description of Event or Problem · 1

    PHYSICIAN DELIVERED ONE RESOLUTE INTEGRITY DRUG ELUTING STENT TO A LESION AT THE LEFT CORONARY SUCCESSFULLY TO TREAT IN STENT RESTENOSIS OF A NON-MEDTRONIC STENT. APPROXIMATELY 5 DAYS LATER STENT THROMBOSIS OCCURRED WHICH WAS TREATED BY ASPIRATION AND POBA. IT IS REPORTED THAT THE PATIENT RECOVERED. OBSERVATION AFTER PCI: THE DISTAL OF THE STENT WAS SLIGHTLY UNDER EXPANSION DUE TO CALCIFICATION. COMMENT FROM PHYSICIAN: THE PATIENT PREVIOUSLY UNDERWENT ANGIOPLASTY AT THE LEG. BECAUSE OF THIS TREATMENT HE HAS BEEN CONTINUED MEDICATION WITH ASPIRIN AND PLETAAL. THIS EVENT IS CONSIDERED DUE TO WEAK EFFICACY OF PLETAAL. THERE IS NO DEVICE RELATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126275 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006259403

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ASPIRIN AND PLETAAL