BEUDAMED
    FDA Adverse Event Death Summary report: N

    SITESEER-6F JR 4.0 100CM DX CATHETER

    MDR report key: 1725491 · Received June 10, 2010

    Report

    Report Number
    1220452-2010-00030
    Event Type
    Death
    Date Received
    June 10, 2010
    Date of Event
    January 13, 2010
    Report Date
    May 12, 2010
    Manufacturer
    MEDTRONIC INC.
    Product Code
    DQO
    PMA / PMN Number
    K932092
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL DEVICE USED DURING THE CASE WAS NOT RETURNED FOR EVALUATION. THEREFORE, AN ENGINEERING ANALYSIS OF THE SUBJECT CAN NOT BE PERFORMED. THE LOT NUMBER FOR THE DEVICE IS KNOWN AND A REVIEW OF THE DEVICE HISTORY RECORD DID NOT DETECT ANY DEFICIENCIES IN THE MANUFACTURING PROCESS. AN UNSTABLE PATIENT WITH KNOWN COMPLEX CORONARY ARTERY DISEASE PRESENTED WITH UNSTABLE ANGINA AND RENAL FAILURE REQUIRING DIALYSIS. THE PATIENT HAD PREVIOUSLY BEEN TURNED DOWN FOR ANGIOPLASTY AS BEING TOO HIGH RISK. IT WAS DECIDED ON THIS OCCASION TO OFFER HIGH RISK INTERVENTION TO FACILITATE RENAL DIALYSIS. UNFORTUNATELY THE PROCEDURE WAS FOLLOWED WITH A DETERIORATING COURSE THAT CAN BE ATTRIBUTED TO RENAL FAILURE, SEVERE CORONARY ARTERY DISEASE, HYPOTENSION, AND HEARTH FAILURE. THE PRESENCE OF MICRO-INFARCTION IS CONSISTENT WITH THE MYOCARDIAL ENZYME RISES SEEN IN THESE COMPLEX PATIENTS AND IS NOT ASSOCIATED WITH THE POLYMERIC COAT OF THE DRUG ELUTING STENTS USED BUT MIGHT IN PART HAVE CONTRIBUTED TO BY THE EMBOLISATION OF MATERIAL FROM THE HYDROPHILIC COATING OF THE GUIDEWIRES, ALTHOUGH IT IS MOST UNLIKELY THAT THIS HYDROPHILIC COATING MATERIAL IS SUFFICIENT TO LEAD TO DEATH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO US THAT A ZINGER LIGHT SUPPORT 180CM WAS USED DURING THIS PROCEDURE. MEDTRONIC WAS MADE AWARE OF THIS INFORMATION ON MAY 12, 2010. THE FOLLOWING DEVICES WERE INSERTED INTO A PATIENT FOR TREATMENT OF A LEFT MAIN AND LAD: 6F INPUT INTRODUCER KIT (MFR REPORT # 1220452-2010-00034); 7F INPUT INTRODUCER KIT (MFR REPORT # 1220452-2010-00035); 7F INPUT INTRODUCER KIT (MFR REPORT # 1220452-2010-00036); LAUNCHER 7F EBU3.75 (MFR REPORT # 1220452-2010-00024); JR CATHETER, 6A0002; JR CATHETER, 6A0085 (MFR REPORT # 1220452-2010-00031); 0.038 PTFE GUIDEWIRE (MFR REPORT # 1220452-2010-00032); 0.038 PTFE GUIDEWIRE (MFR REPORT # 1220452-2010-00033); ZINGER LIGHT SUPPORT 180CM (MFR REPORT # 1220452-2010-00025); 2.00MM X 3.00MM SPRINTER LEGEND RX BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-01086); 2.00MM X 20MM SPRINTER LEGEND RX BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-01087); 3.50 X 20MM SPRINTER LEGEND RX BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-00863); 4.00MM X 12 MM NC SPRINTER RX BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-00864); 3.00MM X 9MM NC SPRINTER BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-01085); 2.25MM X 14MM ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT (MFR REPORT # 2953200-2010-00674); 2.50MM X 14MM ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT (MFR REPORT # 2953200-2010-00675); 3.50MM X 15MM ENDEAVOR RESOLUTE RX DRUG-ELUTING STENT (MFR REPORT # 2953200-2010-00676). LESION MORPHOLOGY WAS REPORTED AS SMALL CALCIFIED DIFFUSELY DISEASED CORONARY ARTERIES WITH SIGNIFICANT STENOSIS OF THE LEFT MAIN, PROXIMAL CX AND LAD AND ORIGIN DIAGONAL. THE LAD AND DIAGONAL WERE PRE-DILATATED, FOLLOWED BY THE IMPLANTATION OF 3 STENTS. THERE WERE NO REPORTED ISSUES ENCOUNTERED WITH USE OF THE MEDTRONIC DEVICES DURING THE INDEX PROCEDURE. THE PATIENT IS REPORTED TO HAVE TOLERATED THE INDEX PROCEDURE REASONABLY WELL AND THERE WAS A GOOD ANGIOGRAPHIC RESULT. THE PATIENT'S CONDITION DETERIORATED AFTER PCI AND WAS TRANSFERRED TO CORONARY CRITICAL CARE. THE POST OPERATIVE COURSE REPORTED EPISODES OF CHEST PAIN AND TROPONIN RISE. REASSESSMENT OF THE CORONARY STENTS WAS COMPLETED 6 DAYS POST THE INDEX PROCEDURE. IT IS REPORTED THAT THE PATIENT HAD AN EMERGENCY RE-CATHETERIZATION. THE PREVIOUSLY IMPLANTED STENTS WERE FOUND TO BE OPEN WITH NO EVIDENCE OF THROMBUS AND THE MAIN ARTERIES WERE OPEN BUT NO FILLING OF THE SMALL SIDE BRANCHES WERE OBSERVED. IN AN ATTEMPT TO PROVIDE EVEN BETTER ANGIOGRAPHIC RESULT, THE FOLLOWING DEVICES WERE USED DURING THE REVASCULARIZATION PROCEDURE, WITHOUT IMPROVEMENT IN THE PATIENT'S CONDITION: 6F INPUT INTRODUCER KIT (REF MFR REPORT # 1220452-2010-00040); 0.038 PTFE GUIDEWIRE (REF MFR REPORT # 1220452-2010-00038); ZINGER LIGHT GUIDEWIRE (REF MFR REPORT # 1220452-2010-00039); 6F EBU 3.75 GUIDE CATHETER (REF MFR REPORT # 1220452-2010-00037); 2.50MM X 20MM SPRINTER LEGEND RX BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-01088); 4.00MM X 20MM SPRINTER LEGEND RX BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-01089); 2.00MM X 20MM SPRINTER LEGEND RX BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-01089); 2.50MM X 9MM NC SPRINTER BALLOON DILATATION CATHETER (MFR REPORT # 2953200-2010-01093); 2.25MM X 12MM ENDEAVOR RESOLUTE DRUG-ELUTING STENT (MFR REPORT # 2953200-2010-01091); MICRO-DRIVER BARE METAL STENT (MFR REPORT # 2953200-2010-01092). THERE WERE NO REPORTED ISSUES ENCOUNTERED WITH USE OF MEDTRONIC DEVICES DURING THIS INTERVENTION. IT IS REPORTED THAT THE PATIENT DIED LATER THAT DAY. AN AUTOPSY WAS PREFORMED WHICH SHOWED EXTENSIVE MYOCARDIAL DAMAGE. THE CASE FILE AND REPORTS IN RELATION TO THE PATIENT WERE MADE AVAILABLE FOR CLINICAL REVIEW. IT IS THE OPINION OF THE CLINICAL REVIEWER THAT THE MOST LIKELY CAUSE OF DEATH CAN BE ATTRIBUTED TO RENAL FAILURE, SEVERE CORONARY ARTERY DISEASE, HYPOTENSION, AND HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SITESEER-6F JR 4.0 100CM DX CATHETER DQO MEDTRONIC INC. NA 20207264

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Death