BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC SPRINTER RX

    MDR report key: 3871853 · Received June 13, 2014

    Report

    Report Number
    9612164-2014-00633
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    LOX
    PMA / PMN Number
    P790017
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: NO RESULTS AVAILABLE SINCE NO EVALUATION WAS PERFORMED (INVESTIGATION IN PROGRESS). INHERENT RISK OF PROCEDURE (PERFORATION). (ROOT CAUSE CANNOT BE DETERMINED). (NO DEVICE RECEIVED FOR EVALUATION). EVALUATION CONCLUSION: UNABLE TO CONFIRM COMPLAINT (INVESTIGATION IN PROGRESS). INHERENT RISK OF PROCEDURE (PERFORATION). CONCLUSION NOT YET AVAILABLE (INVESTIGATION IN PROGRESS). (B)(4).

    Additional Manufacturer Narrative · 1

    EVALUATION METHOD: CINE IMAGE REVIEW. EVALUATION RESULT: RELATED TO OPERATIONAL CONTEXT (VESSEL INJURY DUE TO USE OF DEVICES). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (70% STENOSIS, IMAGE REVIEW SUGGESTS THE LESION WAS RESISTANT TO STENTING/BALLOON). EVALUATION CONCLUSION: OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THE EVENT (VESSEL INJURY DUE TO USE OF DEVICES). DEVICE FAILURE RELATED TO PATIENT CONDITION- (70% STENOSIS, IMAGE REVIEW SUGGESTS THE LESION WAS RESISTANT TO STENTING/BALLOON).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION IN THE LAD OF A PATIENT. THE VESSEL EXHIBITED 70% STENOSIS IN THE MID PORTION OF THE VESSEL. THE LESION HAD BEEN PRE-DILATED WITH A SPRINTER LEGEND 3.0 X 20MM BALLOON, INFLATED TO 18ATMS. THE PHYSICIAN THEN DEPLOYED A 3.5MM DIAMETER X 26MM LENGTH RESOLUTE INTEGRITY RX DRUG ELUTING STENT AT THE LESION SITE INFLATING IT TO 16ATMS. IT WAS CONFIRMED THAT THE STENT HAD BEEN REMOVED FROM PACKAGING AS PER IFU, INSPECTED AND PREPPED WITH NO ISSUES NOTED. THE STENT DID NOT PASS THROUGH A PREVIOUSLY DEPLOYED STENT. NO EXCESSIVE FORCE WAS USED DURING DELIVERY HOWEVER IT CANNOT BE CONFIRMED IF RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE DEVICE. THE PHYSICIAN POST DILATED THE STENT WITH A NC SPRINTER 4.0 X 15MM BALLOON TO 18 ATM. WHEN BALLOON WAS DEFLATED, IT WAS NOTED THAT THE LAD HAD DISSECTED/PERFORATED. THE STENT WAS RIGHT AT THAT LEVEL. THE PATIENT BECAME UNCONSCIOUS AND LOST HER PULSE REQUIRING CPR. THE PATIENT CODED AND SENT FOR EMERGENCY CORONARY BYPASS DURING WHICH TIME, CT SURGEON REMOVED STENT FROM ARTERY. UPON VISUALIZATION, PHYSICIAN THINKS THERE IS A "HOLE" IN THE STENT. SERIAL PATCHES AND 4-0 PROLENE WAS USED TO SUTURE AROUND THE SEGMENT OF THE LAD PROXIMAL TO DISTAL TO THE PERFORATION. WITH THAT, THE BLEEDING WAS CONTROLLED. TWO VEIN GRAFTS WERE PERFORMED- ONE TO THE LAD AND ONE TO THE DIAGONAL ARTERY. THE PATIENT HAS BEEN EXTUBATED AND RECOVERING FROM DOUBLE BYPASS. NO OTHER CLINICAL SEQUELAE WERE REPORTED FOR THIS EVENT.

    Description of Event or Problem · 1

    CINE IMAGE REVIEW: THE PROCEDURAL IMAGES SHOW A LESION IN THE LAD. PRE-DILATION WAS PERFORMED WITH A SPRINTER LEGEND BALLOON. THE RESOLUTE INTEGRITY STENT WAS DEPLOYED WITH SOME RESIDUAL WASTE NOTED IN THE MID-PORTION. THE STENT IS THEN POST-DILATED WITH AN NC SPRINTER DEVICE AFTER WHICH, A PERFORATION WAS OBSERVED IN THE LAD AT THE SITE OF THE DEPLOYED STENT. THERE IS NO EVIDENCE OF BALLOON LEAKS OR STENT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350477 NC SPRINTER RX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX MEDTRONIC MEXICO 208081054

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention