BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINTER OTW

    MDR report key: 4802618 · Received May 28, 2015

    Report

    Report Number
    9612164-2015-00823
    Event Type
    Injury
    Date Received
    May 28, 2015
    Date of Event
    March 28, 2015
    Report Date
    May 11, 2015
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES, RESULTS: UNKNOWN (ROOT CAUSE OF THE DISSECTION IS UNDETERMINED). INHERENT RISK OF PROCEDURE (DISSECTION) NONE (NO DEVICE RETURNED) NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (DEVICE NOT RETURNED FOR EVALUATION) EVALUATION CODES, CONCLUSIONS: - INHERENT RISK OF PROCEDURE (DISSECTION) UNABLE TO CONFIRM COMPLAINT (NO DEVICE RETURNED) - UNKNOWN (ROOT CAUSE OF THE DISSECTION IS UNDETERMINED) - NO DEVICE RETURNED (B)(4).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PHYSICIAN ATTEMPTED TO DELIVER A RESOLUTE INTEGRITY DRUG ELUTING STENT DURING PROCEDURE, TO TREAT A STEMI PATIENT WITH TOTALLY OCCLUDED CIRCUMFLEX AND OM AT THE PROXIMAL END OF THE CIRCUMFLEX VESSEL. THE PROXIMAL CIRCUMFLEX WAS REPORTED TO EXHIBIT LITTLE TORTUOSITY, LITTLE CALCIFICATION AND 100% LESION STENOSIS. THE DEVICE WAS REMOVED FROM PACKAGING PER IFU AND INSPECTED WITH NO ISSUES NOTED. NEGATIVE PREP WAS PERFORMED WITH NO ISSUES IDENTIFIED. THE LESION WAS PRE-DILATED WITH A SEMI COMPLIANT BALLOON. THE PHYSICIAN USED A NON-MEDTRONIC ASPIRATION CATHETER TO ASPIRATE A CLOT IN THE MID CIRCUMFLEX AND OM VESSEL. BOTH THE BALLOON AND ASPIRATION CATHETER CROSSED WITH EASE. IT IS REPORTED THAT DELIVERY OF THE STENT WAS ATTEMPTED AND THE PHYSICIAN FELT RESISTANCE AT THE PROXIMAL CIRCUMFLEX JUST BEFORE THE TAKEOFF OF THE OM AND WOULD NOT ADVANCE. THE PHYSICIAN THEN REMOVED THE RESOLUTE INTEGRITY DES AND INSPECTED TO CHECK FOR ANY DEFORMATION OF THE STENT STRUTS OR KINK IN THE CATHETER. NO ISSUES WERE NOTED. THE PHYSICIAN THEN RE-ATTEMPTED DELIVERY, AND AGAIN FELT RESISTANCE IN THE SAME AREA AS BEFORE. THE DEVICE WOULD NOT CROSS. NO DAMAGE WAS NOTED TO THE STENT UPON REMOVAL, FOLLOWING RE-ATTEMPTED DELIVERY. A NON-MEDTRONIC STENT, OF THE SAME SIZE AND LENGTH, CROSSED EASILY AND WAS DEPLOYED. THE DEVICE DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE BUT EXCESSIVE FORCE WAS NOT USED DURING DELIVERY. IT IS REPORTED THAT AFTER THE ATTEMPTED DELIVERY OF THE RESOLUTE INTEGRITY STENT TWICE UNSUCCESSFULLY, THE CIRCUMFLEX HAD A DISSECTION. THIS WAS TREATED WITH THE NON-MEDTRONIC STENT. CINE IMAGE REVIEW: PROCEDURAL IMAGES FOR THIS EVENT WERE PROVIDED FOR EVALUATION. ON REVIEW OF THESE IMAGES, THE LESION APPEARS TO HAVE A HIGH LEVEL OF STENOSIS AND SLIGHT TORTUOSITY OF THE VESSEL. THE IMAGES ALSO APPEAR TO SHOW TWO ATTEMPTS AT PRE DILATION OF THE LESION WITH A BALLOON SPRINTER OTW 2.5X20 MM AND A BALLOON SPRINTER OTW 3.0X20 MM. THE IMAGES POST THE SECOND PRE DILATION ATTEMPT WITH THE BALLOON SPRINTER OTW 3.0X20 MM SHOW THE VESSEL AND WHAT APPEARS TO BE A REDUCED FLOW IN THE VESSEL. THIS MAY INDICATE THAT THE REPORTED DISSECTION OCCURRED . THERE IS NO EVIDENCE FROM THE RETURNED IMAGES TO SUGGEST ANY DEVICE MALFUNCTION. ADDITIONAL INFORMATION: PROCEDURAL NOTES WERE RECEIVED THAT CONFIRM THE PATIENT VESSEL/LESION MORPHOLOGY AND THE ATTEMPTS TO PRE DILATE THE LESION. CLINICAL REVIEW: MEDTRONIC CLINICAL EXPERTS REVIEWED THE IMAGES FOR THIS CASE AND MET WITH THE PHYSICIAN. IN THIS MEETING, THE PHYSICIAN MENTIONED THAT THE CASE WAS LOT MORE TORTUOUS THAN THE FILMS MAKE IT APPEAR AND THERE WAS A LOT OF CALCIUM PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347135 SPRINTER OTW CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention