BEUDAMED
    FDA Adverse Event Death Summary report: N

    STERLING MONORAIL

    MDR report key: 1062438 · Received June 18, 2008

    Report

    Report Number
    2134265-2008-01701
    Event Type
    Death
    Date Received
    June 18, 2008
    Date of Event
    May 16, 2008
    Report Date
    May 19, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    DQY
    PMA / PMN Number
    K053118
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED OF AT THE USER FACILITY AND WILL NOT BE AVAILABLE FOR ANALYSIS, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PROD FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT # 2134265-2008-01699, 2134265-2008-01700. IT WAS REPORTED THAT POST A CAROTID ARTERY STENTING (CAS) PROCEDURE, A PT DEATH OCCURRED. IT WAS NOTED THAT THE PROCEDURE WAS PERFORMED UNDER GEN ANESTHESIA. THE APPROX 10MM, 80% STENOSED, NON-CALCIFIED LESION WAS LOCATED IN THE SEVERELY TORTUOUS LEFT INTERNAL CAROTID ARTERY (LICA). THE DISTAL LICA WAS APPROX 5.4MM IN DIAMETER AND THE PROXIMAL LICA WAS APPROX 7.8 MM IN DIAMETER. THE PT ALSO REC'D INTRA-OPERATIVE ELECTROCARDIOGRAPHY (ECG) MONITORING AS WELL AS TEMPORAL HEART PACING WITH A SET HEART RATE OF 60 BEATS PER MIN (BPM). ACCESS WAS OBTAINED VIA THE RIGHT FEMORAL ARTERY. ANOTHER MFR'S 8FR INTRODUCER SHEATH WAS PLACED AND 5,000 UNITS OF IV HEPARIN WAS ADMINISTERED TO THE PT. ANOTHER MFR'S GUIDE CATHETER WAS INSERTED, HOWEVER, RESISTANCE WAS ENCOUNTERED UPON ADVANCING THE GUIDE CATHETER THROUGH THE ASCENDING AORTA. IT WAS NOTED THAT THE CATHETER WOULD "FALL DOWN TOWARD THE LEFT VENTRICLE DUE TO THE SHARP ANGLE BETWEEN THE ASCENDING AORTA AND LEFT COMMON CAROTID ARTERY". ANOTHER MFR'S GUARD WIRE OCCLUSION SYS WAS PLACED DISTAL TO THE LESION. THE STERLING 4.0 MM X 20 MM BALLOON CATHETER WAS ADVANCED TO THE LESION FOR PRE-DILATATION, HOWEVER, THE NUMBER OF INFLATIONS AND TO WHAT ATMS THE BALLOON REACHED IS UNK. THE GUARD WIRE WAS INFLATED FOR 3 MINS 30 SECONDS TO OCCLUDE BLOOD FLOW WHILE PRE-DILATATION WAS PERFORMED. THE WALLSTENT 9 MM X 18MM X 135 MM STENT DELIVERY SYS WAS ADVANCED TO THE LESION AND SUCCESSFULLY DEPLOYED. THE GUARD WIRE WAS AGAIN INFLATED FOR 3 MINS 20 SECONDS TO OCCLUDE BLOOD FLOW WHILE STENTING WAS PERFORMED. THE STERLING 6.0 MM X 20 MM BALLOON CATHETER WAS ADVANCED TO THE LESION FOR POST-DILATATION. THE PHYSICIAN INFLATED THE BALLOON TO 6 ATM FOR 20 SECONDS THEN, FOR UNSPECIFIED REASONS, BRIEFLY INCREASED THE PRESSURE TO 14ATMS IMMEDIATELY PRIOR TO DEFLATION. THE GUARD WIRE WAS INFLATED FOR 3 MINS 35 SECONDS TO OCCLUDE BLOOD FLOW WHILE POST-DILATATION WAS PERFORMED. WHILE BLOCKING BLOOD FLOW WITH THE GUARD WIRE, ANOTHER MFR'S ASPIRATION CATHETER WAS ADVANCED TO THE LESION TO EVACUATE "CLOT AND PLAQUE AROUND THE LESION FROM THE PROXIMAL PART OF THE BALLOON TO THE DISTAL ENDO OF THE GUIDE CATHETER". IT WAS NOT KNOWN HOW LONG THE GUARD WIRE WAS INFLATED DURING ASPIRATION. ANOTHER MFR'S VASCULAR CLOSURE DEVICE WAS USED TO CLOSE THE ACCESS SITE, HOWEVER, THIS WAS UNSUCCESSFUL IN CONTROLLING BLEEDING. THE PHYSICIAN APPLIED MANUAL PRESSURE FOR AN UNSPECIFIED AMOUNT OF TIME TO THE FEMORAL ARTERY TO SUCCESSFULLY CONTROL BLEEDING AND COMPLETE THE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT WHILE ADVANCING DEVICES THROUGH THE ASCENDING AORTA, TEMPORAL PACING WAS "OFTEN ACTIVATED". IT WAS FURTHER NOTED THAT ECG REVEALED "NO PROBLEMS UPON BLOCKING" THE LICA DURING PRE-DILATION, STENTING, AND POST-DILATATION. IN ADDITION, EACH OCCLUSION WAS CHECKED WITH DIGITAL SUBTRACTION ANGIOGRAPH (DSA), HOWEVER, NO RESULTS WERE REPORTED. THE TOTAL PROCEDURE TIME WAS APPROX 1 HR 35 MINS. UPON ATTEMPTING TO WAKE THE PT FROM ANESTHESIA, SPONTANEOUS BREATHING WAS NOTED, HOWEVER, THE PT'S HEART RATE WAS 110 BPM AND THE PT EXHIBITED SIGNS OF BRAIN INFARCT WITH NEAR COMPLETE ACROPARALYSIS. IT WAS NOTED THAT "THE PT LAY FACE UP AND LOOKED LEFT, HAD BECOME PARALYZED ON THE RIGHT SIDE OF THE BODY, AND COULD ONLY MOVE THE HAND ON THE LEFT SIDE." IT WAS FURTHER NOTED THAT THE PT EXHIBITED "CONTINUOUS COLD SWEATS". CT IMAGING WAS PERFORMED WITH NO ANOMALIES NOTED. A FEW HRS LATER, TEMPORAL PACING WAS REMOVED AND AN MRI SCAN WAS PERFORMED. DIFFUSION-WEIGHTED IMAGES REVEALED THAT "EMBOLUS WAS FOUND ON BOTH SIDES OF THE CEREBRAL HEMISPHERE AND CEREBELLUM". A FEW HRS LATER, THE PT BEGAN TO BREATHE "UNSTEADILY" AND BLOOD PRESSURE BEGAN TO FALL. THE PT WAS ADMINISTERED AN UNSPECIFIED VASOSUPRESSOR AND PLACED ON A VENTILATOR. APPROX 3 HRS LATER, THE PT'S BLOOD PRESSURE DECREASED FURTHER AND THE PT SUFFERED CARDIAC ARREST. IN AN ATTEMPT TO RECOVER HEART FUNCTION, CPR WAS PERFORMED BUT WAS UNSUCCESSFUL. THE PT HAD NOT SUFFERED ANY PREVIOUS MAJOR OR MINOR STROKES, WAS ASYMPTOMATIC FOR STROKE PRIOR TO THE PROCEDURE, AND WAS REPORTEDLY ABLE TO "WALK BY HIMSELF" UPON ADMISSION. IN THE PHYSICIAN'S OPINION, AN "EMBOLIC SHOWER RELEASED DURING ADVANCING DEVICES THROUGH THE ASCENDING AORTA IS SUSPECTED TO BE THE CAUSE" OF THE INFARCTION ON BOTH SIDES OF THE BRAIN. AN AUTOPSY HAS BEEN PERFORMED, HOWEVER, THE RESULTS ARE NOT IMMEDIATELY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERLING MONORAIL DQY CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death 8FR 25CM SHEATH INTRODUCER (TERUMO)| ENCORE26 ADVANTAGE KIT| PERCUSURGE GUARD WIRE .014 X 300 CM| ZUMA2 8FR (MEDTRONIC)