BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR RX IDE

    MDR report key: 2133414 · Received June 14, 2011

    Report

    Report Number
    9612164-2011-00568
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    July 10, 2011
    Report Date
    February 29, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: INHERENT RISK OF PROCEDURE (DEATH). (B)(4).

    Additional Manufacturer Narrative · 1

    .

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS: (CVA/STROKE).

    Description of Event or Problem · 1

    THE PREVIOUSLY REPORTED DEATH OCCURRED APPROXIMATELY 2 YEARS AND 4 MONTHS POST THE INDEX PROCEDURE. 6 DAYS PRIOR TO DEATH THE PATIENT SUFFERED A STROKE "PATIENT ADMITTED WITH RIGHT SIDED WEAKNESS. ADMITTED AFTER OUTPATIENT MRI SHOWED SUB-ACUTE STROKE. CT SCAN COMPLETED. PATIENT LEFT NEXT DAY AMA" 2 DAYS LATER, THE PATIENT SUFFERED SECOND STROKE "PATIENT READMITTED (AFTER LEAVING AMA) FOR RIGHT HEMIPLEGIA. A TEE WAS PERFORMED. A PAPILLARY FIBROELASTOMA WAS FOUND AND DECIDED TO TREAT MEDICALLY."

    Description of Event or Problem · 1

    CLINICAL EVENTS COMMITTEE (CEC) ADJUDICATED THAT THE PREVIOUSLY REPORTED STROKE EVENT DATES WERE (B)(6) 2010 NOT (B)(6) 2010 AS PREVIOUSLY REPORTED; (B)(6) 2011 NOT (B)(6) 2011 AS PREVIOUSLY REPORTED; THE PATIENT SUFFERED ANOTHER PREVIOUSLY REPORTED STROKE ON THE (B)(60 2011 WHICH WAS APPROXIMATELY 1 MONTH POST PREVIOUS STROKE NOT 2 DAYS LATER AS PREVIOUSLY REPORTED. THE CEC HAVE ALSO ADJUDICATED THAT THE PATIENT SUFFERED A STROKE 1 DAY PRIOR TO DEATH. THE CAUSE OF DEATH HAS BEEN REPORTED AS INTRACRANIAL HAEMORRHAGE.

    Description of Event or Problem · 1

    THE PT UNDERWENT THE INDEX PROCEDURE WITH PRE-TREATMENT BALLOON ANGIOPLASTY AND DELIVERY OF AN ENDEAVOR RAPID EXCHANGE (RX) DRUG ELUTING STENT IN THE PROXIMAL CX. THERE WERE NO CLINICAL SEQUELAE. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED AND THE PT WAS DISCHARGED ON ASA AND CLOPIDOGREL. THE SITE REPORTED A TIA APPROX 14 MONTHS POST INDEX PROCEDURE. ACCORDING TO A HISTORY AND PHYSICAL REPORT THE PT HAS A HISTORY OF BIPOLAR DISORDER AND WAS HOSPITALIZED APPROX 13 MONTHS POST INDEX PROCEDURE FOR LITHIUM TOXICITY AND SECONDARY ACUTE KIDNEY INJURY. SINCE THAT EPISODE, THE PT CONTINUED TO EXPERIENCE RIGHT SIDED WEAKNESS AND SLURRED SPEECH. THE REPORT FURTHER NOTED HE WAS EVALUATED AT A NEUROLOGY CLINIC AND AN MRI WAS PERFORMED APPROX 14 MONTHS POST INDEX PROCEDURE WHICH REVEALED FOCAL AREAS OF ENCEPHALOMALACIA MOST COMPATIBLE WITH SMALL, CHRONIC INFARCTS NOTED IN THE LEFT INSULA AND LEFT POSTERIOR-FRONTAL CORTEX. NONSPECIFIC, PATCHY T2 AND FLAIR SIGNAL HYPERINTENSITY IN THE LEFT FRONTOPARIETAL PERIVENTRICULAR WHITE MATTER. TWO DAYS LATER THE PT WAS RE-HOSPITALIZED FOR INCREASED WEAKNESS, BLURRY VISION, AND SLURRED SPEECH PRIOR TO ARRIVAL, DID NOT HAVE SLURRED SPEECH UPON ADMISSION. A CT SCAN REVEALED EVIDENCE OF PRIOR INFARCTS IN THE LEFT CEREBRUM AND NO NEW OR ACUTE PATHOLOGY. A REPEAT MRI PERFORMED ONE DAY LATER WHICH SHOWED NO CHANGE FROM PREVIOUS EXAM. THE MRI REPORT NOTED FACIAL NUMBNESS AS AN INDICATION FOR THE TEST. A TEE REVEALED A SMALL, MOBILE, ECHOGENIC DENSITY ATTACHED TO THE MITRAL SUBVALVULAR APPARATUS OR THE LEFT VENTRICULAR ENDOCARDIUM, LIKELY REPRESENTING FIBROELASTOMA. IT WAS REPORTED THAT THE NEUROLOGICAL DEFICITS LASTED >24 HOURS; BUT RESOLVED. THE PT WAS DISCHARGED WITH INSTRUCTIONS TO F/U WITH THE NEUROLOGIST IN ONE WEEK.

    Description of Event or Problem · 1

    APPROXIMATELY 1 YEAR FROM THE INDEX PROCEDURE, IT WAS REPORTED THAT THE PATIENT FELL AT HOME AND CALLED 911. PATIENT WAS INTUBATED IN THE FIELD DUE TO RESPIRATORY DISTRESS AND GCS=3. CT SCAN OF HEAD PERFORMED. RIGHT SIDE OF SKULL WAS FRACTURED AND MULTIPLE HAEMORRHAGES NOTED. SECOND CT SCAN COMPLETED WITH WORSENING HAEMORRHAGES AND MILD HYDROCEPHALUS. THERE WAS A LEFT TO RIGHT MIDLINE SHIFT. IT WAS REPORTED THAT THERE WAS NOTHING MORE THAT COULD BE OFFERED AND PATIENT DEATH OCCURRED. IT WAS REPORTED THAT THIS EVENT WAS NOT RELATED TO THE STUDY DEVICE/DRUG/PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR RX IDE STENT, CORONARY, DRUG-ELUTING NIQ MEDTRONIC IRELAND NA 0000505832

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Death| H