BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDEAVOR SPRINT RX CORONARY STENT SYSTEM

    MDR report key: 2133363 · Received June 16, 2011

    Report

    Report Number
    9612164-2011-00581
    Event Type
    Death
    Date Received
    June 16, 2011
    Date of Event
    February 26, 2011
    Report Date
    October 31, 2014
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (DEATH, MI), (ROOT CAUSE UNKNOWN).

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT THE INDEX PROCEDURE WITH PRE-TREATMENT BALLOON ANGIOPLASTY AND DELIVERY OF TWO OVERLAPPING ASSIGNED STENTS IN THE MID LAD (REFERENCE MFR REPORT NUMBER 9612164201100582). THERE WERE NO CLINICAL SEQUELAE. THE ANGIOGRAPHIC CORE LAB REPORTED A 24% FINAL RESIDUAL IN-LESION STENOSIS WITH NO DISSECTION AND TIMI 3 FLOW. THE POST-PROCEDURE COURSE WAS UNCOMPLICATED AND THE PATIENT WAS DISCHARGED ON ASA AND CLOPIDOGREL. APPROXIMATELY 6 MONTHS LATER, THE PATIENT WAS REHOSPITALIZED FOR A SITE REPORTED NSTEMI. ACCORDING TO THE DISCHARGE SUMMARY, THE PATIENT COMPLAINED OF ONE EPISODE OF EPIGASTRIC PAIN ACCOMPANIED WITH VOMITING WHICH RESOLVED. A REPEAT ANGIOGRAPHY FOR RECURRENT CLINICAL SYMPTOMS REVEALED A 23% IN-STENT RESTENOSIS REPORTED BY THE ANGIOGRAPHIC CORE LAB. THE CARDIAC CATHETERIZATION REPORT NOTED A PATENT STENT IN THE PROXIMAL LAD, A PATENT STENT WITH A 40% STENOSIS IN THE MID LAD, A 70% OSTIAL PROXIMAL CX STENOSIS, A 50% MID CX STENOSIS AND WAS CALCIFIED WITH DIFFUSE DISEASE, THE 1ST OM HAD A 75% STENOSIS AND WAS DIFFUSELY DISEASED, THE OSTIAL PROXIMAL RCA HAD A 90% STENOSIS AND WAS CALCIFIED WITH DIFFUSE DISEASE, AND THE MID RCA WAS CHRONICALLY TOTALLY OCCLUDED. THE DISCHARGE SUMMARY FURTHER NOTED THAT NO INTERVENTION WAS PERFORMED AS THERE WERE NO CULPRIT LESION, ANGINA, AND THE CORONARY ARTERIES WERE HEAVILY CALCIFIED WHICH WOULD MAKE STENT PLACEMENT DIFFICULT AND RISKY. IT WAS RECOMMENDED THAT THE PATIENT BE TREATED MEDICALLY. PATIENT WAS TREATED WITH ASA AND LOVENOX, AND INSTRUCTED TO CONTINUE WITH CURRENT MEDICATION REGIMEN. ONE YEAR LATER, THE PATIENT WAS REHOSPITALIZED FOR A SITE REPORTED SORE THROAT AND HEMOPTYSIS. A HISTORY AND PHYSICAL NOTED THAT THE PATIENT WAS MEDICALLY MANAGED FOR DYSPNEA RELATED TO CHRONIC EFFUSIONS, AND TWO EPISODES OF HEMOPTYSIS. THE PATIENT REPORTED THAT THE VOLUME OF BLOOD DURING THE TWO EPISODES WAS APPROXIMATELY ONE TEASPOON, AND EXPERIENCED BLOOD-TINGED BURGUNDY SPUTUM OVER THE PAST TWO WEEKS, ACCOMPANIED WITH A SORE THROAT, AND AN UNPLANNED WEIGHT LOSS OF APPROXIMATELY (B)(6) OVER 2 YEARS. THE HISTORY AND PHYSICAL FURTHER NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS INITIALLY 95/64 AND WAS GIVEN INTRAVENOUS FLUID WITH IMPROVEMENT IN HIS SYSTOLIC BLOOD PRESSURE RISING TO THE 120'S. THE SITE REPORTED THAT NO BLOOD TRANSFUSIONS WERE GIVEN. THE PATIENT CONTINUED ON ASA AND CLOPIDOGREL MEDICATION REGIMEN. THE PATIENT WAS ALSO UNDER MEDICAL TREATMENT FOR FEVER AND LEUKOCYTOSIS WHICH RESOLVED SPONTANEOUSLY. A TTE REVEALED AN EF OF 40-50% WITH MODERATE/SEVERE LVH, DILATED RA/RV AND MILD MR. A CT OF THE CHEST REVEALED IMPROVEMENT IN PERICARDIAL AND PLEURAL EFFUSIONS, AND NO OTHER ABNORMALITIES. A CHEST X-RAY PERFORMED REVEALED BILATERAL PLEURAL EFFUSIONS, WITH ATELECTASIS, AND/OR PNEUMONITIS IN THE LEFT LOBE BEING GREATER THAN ON THE RIGHT. THE DISCHARGE SUMMARY NOTED THAT THE X-RAY APPEARED UNCHANGED. THE PATIENT UNDERWENT A THORACENTESIS AT AN OUTLYING FACILITY ONE MONTH EARLIER, AND THE PLEURAL EFFUSIONS WERE NOTED TO HAVE RETURNED; HOWEVER, APPEARED STABLE. THE PATIENT UNDERWENT A (B)(6) AND VASCULARITIS WORK-UP WHICH WAS NEGATIVE. THE PATIENT WAS FOUND TO HAVE AN ACUTE ON CHRONIC CONGESTIVE HEART FAILURE, WHICH WAS THOUGHT TO BE THE CAUSE OF THE HEMOPTYSIS, BASED UPON AN ELEVATED BRAIN NATRIURETIC PEPTIDE WAS 1351. THE PATIENT UNDERWENT GENTLE DIURESIS, AND CAPTOPRIL WAS INTRODUCED INTO THE MEDICATION REGIMEN; HOWEVER, THE PATIENT BECAME ORTHOSTATIC. THE CK AND CKMB'S WERE NEGATIVE HOWEVER THE PATIENT BECAME ORTHOSTATIC. THE CK AND CKMB'S WERE NEGATIVE; HOWEVER, THE TROPONIN WHICH WAS INITIALLY 0.18 DECREASED TO 0.14 (THE RANGE FOR THE PATIENT HAD BEEN TRENDING BETWEEN 0.8 AND 0.16 OVER THE PAST YEAR). AN ECG REVEALED NSR WITH AN LV STRAIN PATTERN IN V5-V6; OLD ANT/SEPTAL INFARCT; TWI IN II, III AND AVF. A CT OF THE HEAD WAS PERFORMED ON (B)(6) 2010 DUE TO THE PATIENT EXPERIENCING A FALL SECONDARY TO A SYNCOPE WITH REVEALED CEREBELLAR ENCEPHALOMALACIA, STATUS POST REMOTE RIGHT FRONTOPARIETAL CRANIOTOMY, AND NO SIGNIFICANT ACUTE ABNORMALITY. EPISODES OF CHEST PAIN AND CONGESTIVE HEART FAILURE OCCURRED AT VARIOUS DATES FOLLOWING THE INDEX PROCEDURE. A SUDDEN PATIENT DEATH IS REPORTED TO HAVE OCCURRED APPROXIMATELY 22 MONTHS FOLLOWING INDEX PROCEDURE. INVESTIGATOR ASSESSED THE EVENT AS REMOTELY RELATED TO THE STUDY DEVICE. CAUSE OF DEATH IS UNKNOWN. IT WAS REPORTED THAT DEATH WAS NOT ASSOCIATED WITH AN MI AND THERE WAS NO EVIDENCE OF STENT THROMBOSIS.

    Description of Event or Problem · 1

    CAUSE OF DEATH WAS CONGESTIVE HEART FAILURE. (REFERENCE MFR REPORT NUMBERS 9612164201100581 <(>&<)> 9612164201100582).

    Description of Event or Problem · 1

    IT IS REPORTED THAT THE PATIENT SUFFERED AN MI ON THE SAME DAY AS THE INDEX PROCEDURE. CEC ADJUDICATED THAT THE EVENT WAS CONSISTENT WITH AN ARC MI. PATIENT WAS RECOVERED AND DISCHARGED 2 DAYS LATER. NO OTHER CLINICAL SEQUELAE WERE REPORTED.

    Description of Event or Problem · 1

    INVESTIGATOR INDICATED THAT THE CHF AND DEATH EVENTS WERE NOT RELATED TO THE STUDY DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX CORONARY STENT SYSTEM NIQ MEDTRONIC IRELAND NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Death ASA| CLOPIDOGREL