BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 2950015 · Received February 8, 2013

    Report

    Report Number
    9612164-2013-00146
    Event Type
    Injury
    Date Received
    February 8, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 11, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS AND CONCLUSION: DISSECTION. SEVERE TORTUOSITY AND MODERATE CALCIFICATION EVALUATION. (B)(4).

    Description of Event or Problem · 1

    A RESOLUTE INTEGRITY DRUG ELUTING STENT (3.5X18MM) WAS DEPLOYED IN PROXIMAL RCA WHICH WAS REPORTED TO EXHIBIT SEVERE TORTUOSITY, MODERATE CALCIFICATION AND 30% STENOSIS FOLLOWING PRE- DILATATION. POST DEPLOYMENT A DISTAL EDGE DISSECTION WAS NOTICED .THE PHYSICIAN ATTEMPTED TO IMPLANT A SECOND RESOLUTE INTEGRITY DRUG ELUTING STENT (2.25X8MM) IN TREATMENT . NO ABNORMALITY WAS NOTED DURING PREPARATION OF THE RESOLUTE DEVICE; HOWEVER, DURING ATTEMPTED DELIVERY THE RESOLUTE DISLODGED PRIOR TO THE LESION IN THE OSTIUM; PROXIMAL TO PREVIOUSLY DEPLOYED STENT. A SPRINTER LEGEND BALLOON WAS USED TO GET INSIDE THE DISLODGED RESOLUTE. THIS WAS THEN PRECEDED WITH MULTIPLE BALLOON SIZES AND WENT ALL THE WAY UP TO A 3.5 BALLOON TO EXPAND STENT. PATIENT IS REPORTED TO BE FINE POST PROCEDURE. PROCEDURAL IMAGE REVIEW: THE PROCEDURAL IMAGES SHOW A PROXIMAL RCA LESION WITH SIGNIFICANT STENOSIS AND TORTUOSITY. PRE-DILATIONS ARE PERFORMED AND A STENT IS DEPLOYED. A DISSECTION CAN BE SEEN AT THE DISTAL EDGE OF THE DEPLOYED STENT. THE FOLLOWING IMAGES SHOW A DISLODGED STENT PROXIMAL TO THE DEPLOYED STENT AT THE OSTIUM OF THE RCA. THIS DISLODGED STENT IS SUCCESSFULLY POSITIONED AND DEPLOYED DISTAL TO THE DEPLOYED STENT TO TREAT THE DISSECTION. THE FINAL CAG SHOWS A GOOD OUTCOME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54291 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention