BEUDAMED
    FDA Adverse Event Death Summary report: N

    DIALYSIS UNKNOWN

    MDR report key: 22180253 · Received June 10, 2025

    Report

    Report Number
    1282497-2025-00402
    Event Type
    Death
    Date Received
    June 10, 2025
    Date of Event
    November 22, 2023
    Report Date
    June 16, 2025
    Manufacturer
    COVIDIEN LLC
    Product Code
    MSD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A4, G3, MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    AHMED E ALI, ALIAN AL-BALAS, PAUL V BENSON AND AMMAR ALMEHMI FATAL SUPERIOR VENA CAVA RUPTURE COMPLICATING DIALYSIS CATHETER EXCHANGE THE JOURNAL OF VASCULAR ACCESS ARTICLE REUSE GUIDELINES: SAGEPUB.COM/JOURNALS-PERMISSIONS DOI: 10.1177/11297298231219288. JOURNALS.SAGEPUB.COM/HOME/JVA MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    PLI 10: ACCORDING TO THE LITERATURE, A 25-YEAR-OLD FEMALE WITH A HISTORY OF MULTIPLE DIALYSIS ACCESS FAILURES PRESENTED FOR AN EXCHANGE OF A TUNNELED CENTRAL VENOUS CATHETER (CVC) VIA THE LEFT INTERNAL JUGULAR VEIN. THE PATIENT MEDICAL HISTORY INCLUDED HYPERTENSION, CONGESTIVE HEART FAILURE WITH A REDUCED EJECTION FRACTION OF 25%, AND END-STAGE KIDNEY DISEASE (ESKD). IN AUGUST 2022, PATIENT HAD BEEN ADMITTED FOR THE CREATION OF A NEW RIGHT UPPER ARM ARTERIOVENOUS GRAFT (AVG) AND EXCHANGE OF HER LEFT INTERNAL JUGULAR (IJ) CVC DUE TO CATHETER DYSFUNCTION ATTRIBUTED TO RETRACTION. DURING THE PROCEDURE, A SINGLE STIFF GLIDE WIRE (0.035", 180 CM; TERUMO, NJ) WAS ADVANCED THROUGH ONE PORT OF THE EXISTING CATHETER INTO THE INFERIOR VENA CAVA (IVC). THE OLD CVC WAS THEN REMOVED ALONG THE PREVIOUS TUNNEL. A 23 CM PRECISION CATHETER WAS INSERTED OVER THE GUIDEWIRE USING THE PROVIDED STIFFENERS AND ADVANCED TOWARD THE CENTRAL CIRCULATION. HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED AT THE JUNCTION OF THE SUPERIOR VENA CAVA (SVC) AND RIGHT ATRIUM. DURING THE PROCEDURE THE WIRE WAS RETRACTED INTO WHAT WAS BELIEVED TO BE THE RIGHT VENTRICLE. SEVERAL ATTEMPTS TO REDIRECT THE GUIDEWIRE INTO THE IVC (INFERIOR VENA CAVA) AT THIS POINT, SVC STENOSIS WAS SUSPECTED. THE PATIENT EXPERIENCED ACUTE CARDIOPULMONARY DECOMPENSATION AND RAPIDLY DEVELOPING TO CARDIOPULMONARY ARREST. PERICARDIAL TAMPONADE WAS SUSPECTED, PROMPTING THE PLACEMENT OF A PERICARDIAL DRAINAGE CATHETER, WHICH YIELDED 100 ML OF BLOOD. DESPITE THESE INTERVENTIONS, THE PATIENT EXPIRED WITHIN ONE HOUR. POSTMORTEM AUTOPSY SHOWED A 2 MM TRANSMURAL, INTRAPERICARDIAL DEFECT IN THE SVC WALL, CONSISTENT WITH VASCULAR PERFORATION. ADDITIONALLY, A SEVERE, ORGANIZED STENOSIS OF THE SVC JUST ABOVE THE SVC¿RIGHT ATRIAL JUNCTION WAS NOTED. FATAL SUPERIOR VENA CAVA RUPTURE COMPLICATING DIALYSIS CATHETER EXCHANGE-THE JOURNAL OF VASCULAR ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1670765 DIALYSIS UNKNOWN CATHETER, HEMODIALYSIS, IMPLANTED MSD COVIDIEN LLC DIALYSIS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Unknown Death| O| R