BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESOLUTE INTEGRITY RX

    MDR report key: 3871851 · Received June 13, 2014

    Report

    Report Number
    9612164-2014-00632
    Event Type
    Injury
    Date Received
    June 13, 2014
    Date of Event
    May 14, 2014
    Report Date
    June 19, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P110013
    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 (EVALUATION IN PROGRESS). INHERENT RISK OF PROCEDURE (PERFORATION). (ROOT CAUSE CANNOT BE DETERMINED). EVALUATION CONCLUSION: UNABLE TO CONFIRM COMPLAINT (EVALUATION IN PROGRESS). INHERENT RISK OF PROCEDURE (PERFORATION). CONCLUSION NOT YET AVAILABLE: EVALUATION IN PROGRESS. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION: CINE IMAGE REVIEW. RELATED TO OPERATIONAL CONTEXT (VESSEL INJURY DUE TO USE OF DEVICES). DEFORMATION PROBLEM. PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (70% STENOSIS, IMAGE REVIEW SUGGESTS THE LESION WAS RESISTANT TO STENTING/BALLOON). 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). (B)(4).

    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 3.5 MM 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

    DEVICE EVALUATION: ONLY THE RESOLUTE INTEGRITY STENT WAS RETURNED. ON REVIEW IT WAS SEVERELY DEFORMED AND STRETCHED. NO STENT FRACTURE WAS DETECTED. 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
    351053 RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND 0007016118

    Patients

    Seq Age Sex Outcome Treatment
    1 00061 YR Required Intervention