BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 10128519 · Received June 8, 2020

    Report

    Report Number
    3009211636-2020-00110
    Event Type
    Injury
    Date Received
    June 8, 2020
    Date of Event
    March 1, 2020
    Report Date
    June 22, 2020
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    TITLE AORTIC VALVE CUSP ANEURYSM AS A RESULT OF BLOOD CULTURENEGATIVE INFECTIVE ENDOCARDITIS, INTERESTING ECHOCARDIOGRAPHIC AND SURGICAL I MAGES SOURCE ECHOCARDIOGRAPHY, VOLUME 37, 2020 (469¿471) DATE OF PUBLICATION: 17 JANUARY 2020. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THIS EVENT HAS BEEN REASSESSED AND FOUND TO BE A NON-MDR REPORTABLE COMPLAINT. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ACCORDING TO LITERATURE SOURCE OF STUDY PERFORMED ON A HYPERTENSIVE AND DIABETIC MALE WITH A ONE-YEAR HISTORY OF ESRD (END-STAGE RENAL DISEASE) UNDER HEMODIALYSIS WHO COMPLAINED OF ABDOMINAL PAIN AND MELENA. IT WAS REPORTED THAT THE PATIENT HAD ¿A LONG-TERM DIALYSIS CATHETER OF A PERMCATH TYPE¿ IN THE RIGHT SUBCLAVIAN VEIN. THE PHYSICAL EXAM NOTES 2+ PITTING EDEMA OF LOWER EXTREMITIES AND A HOLODIASTOLIC BLOWING MURMUR AT THE LEFT UPPER STERNAL BORDER. A TEE (TRANSESOPHAGEAL ECHOCARDIOGRAPHY) AND TTE (TRANSTHORACIC ECHOCARDIOGRAM) REVEALED THREE MASSES ATTACHED TO THE AORTIC VALVE RESULTING IN LEFT VENTRICULAR OUTFLOW AND RESULTING IN SEVERE AORTIC REGURGITATION. THE BLOOD SPECIMENS DRAWN FROM THE PERMANENT CATHETER AND PERIPHERAL VEIN WERE SENT FOR CULTURE WHICH WHERE ALL NEGATIVE FOR BACTERIAL GROWTH. THE AORTIC VALVE REPLACEMENT WAS PERFORMED, AND HISTOPATHOLOGICAL EXAMINATION OF THE AORTIC VALVE CONFIRMED THE DIAGNOSIS OF ACUTE INFECTIVE ENDOCARDITIS. THE SUBCLAVIAN PERMANENT CATHETER WAS REPLACED WITH FEMORAL DIALYSIS CATHETER. IT WAS ALSO STATED THAT INFECTIVE ENDOCARDITIS WAS COMMON IN PATIENTS USING DIALYSIS CATHETERS AND MOST COMMONLY AFFECTS MITRAL AND TRICUSPID VALVES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591749 DIALYSIS UNKNOWN CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention