BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3161305 · Received June 11, 2013

    Report

    Report Number
    9612164-2013-00631
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    February 4, 2013
    Report Date
    July 9, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (LESION MORPHOLOGY¿ HEAVILY CALCIFIED, MODERATE TORTUOSITY). INHERENT RISK OF PROCEDURE ¿ (FAILURE TO DELIVER STENT AND STENT DEFORMATION). DEFORMATION PROBLEM EVALUATION CODES, CONCLUSIONS: INHERENT RISK OF PROCEDURE¿ (FAILURE TO DELIVER STENT AND STENT DEFORMATION). (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: VESSEL/LESION MORPHOLOGY MAY HAVE HINDERED DELIVERY OF THE DEVICE AND RESULTED IN DISLODGEMENT OF THE STENT. PRESENCE OF A PREVIOUSLY DEPLOYED STENT MAY HAVE CONTRIBUTED TO THE STENT DISLODGEMENT. CONCLUSIONS: VESSEL/LESION MORPHOLOGY MAY HAVE HINDERED DELIVERY OF THE DEVICE AND RESULTED IN DISLODGEMENT OF THE STENT. (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PHYSICIAN WAS ATTEMPTING TO IMPLANT A RESOLUTE INTEGRITY DRUG ELUTING STENT IN A HEAVILY CALCIFIED RCA/ PDA BRANCH WITH MODERATE TORTUOSITY. ANOTHER STENT HAD BEEN PREVIOUSLY DEPLOYED AT THE LESION SITE OVER 12 MONTHS BEFORE THIS PROCEDURE. 20-30% STENOSIS REMAINED AFTER PRE-DILATION. IT IS REPORTED THAT THE STENT WIRE UNCOILED OFF THE BALLOON PRIOR TO DEPLOYMENT. THE PATIENT WENT TO SURGERY. PATIENT WENT TO INTENSIVE CARE AND AN ECHO WAS TO BE PERFORMED AT LATER DATE TO CHECK FOR VENTRICULAR DAMAGE. THERE WAS NO DIFFICULTY REPORTED DURING REMOVAL OF THE RESOLUTE INTEGRITY AFTER FAILURE TO DEPLOY THE STENT. THE PHYSICIAN WAS UNABLE TO DELIVER ANY OTHER STENT TO THE LESION. THE LESION WAS SUBSEQUENTLY TREATED WITH BALLOON ANGIOPLASTY PATIENT STATUS POST PROCEDURE IS STABLE.

    Description of Event or Problem · 1

    EVALUATION SUMMARY: THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS AS PER SPECIFICATIONS. THE 1ST PROXIMAL STENT SEGMENT WAS RAISED AND DEFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    263290 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0006057280

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention