BEUDAMED
    FDA Adverse Event Death Summary report: N

    EOPA ARTERIAL CANNULA

    MDR report key: 12120036 · Received July 6, 2021

    Report

    Report Number
    2184009-2021-00054
    Event Type
    Death
    Date Received
    July 6, 2021
    Date of Event
    May 24, 2021
    Report Date
    August 22, 2022
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DWF
    UDI-DI
    00763000135652
    PMA / PMN Number
    K031037
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION PATIENT CODES (IME/ANNEX E): E050602 HAS BEEN ADDED TO THE PATIENT CODES FOR THIS EVENT. 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

    ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE ACRONYMS USED TO DESCRIBE THE CASE. TQT: PATIENT WITH TRACHEOSTOMY CANNULA CVC: TRILUMEN CENTRAL VENOUS CATHETER IMV: INVASIVE MECHANICAL VENTILATION SNY WITH NET: NASOJEJUNAL TUBES WITH ENTERAL FEEDING. 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

    CONCLUSION: AFTER INVESTIGATION THE COMPLAINT IS CONFIRMED FOR FRACTURE OF THE CANNULA BASED ON THE PHOTO PROVIDED, HOWEVER, NO PRODUCT HAS BEEN RETURNED TO DATE. A ROOT CAUSE OF THIS OCCURRENCE CANNOT BE DETERMINED WITHOUT RETURNED PRODUCT, BUT BASED ON COMPLAINT EVENT DETAILS, THIS COMPLAINT IS MOST LIKELY THE RESULT OF A USE-RELATED ISSUE. THE INSTRUCTIONS FOR USE INDICATE THAT THE CANNULA REPORTED IN THIS COMPLAINT ¿IS INTENDED FOR USE WITH CARDIOPULMONARY BYPASS AS AN ARTERIAL RETURN CANNULA¿ ONLY AND IS NOT INDICATED FOR USE DURING EXTRA CORPOREAL MEMBRANE OXYGEN (ECMO) THERAPY. ADDITIONALLY, THE CANNULA IS ONLY INTENDED TO BE USED IN THE ASCENDING AORTA AND IS NOT INDICATED FOR USE IN THE RIGHT JUGULAR VEIN. THE OFF-LABEL USE OF THE CANNULA FOR AN EXTENDED PERIOD (12 DAYS) ON ECMO COULD HAVE RESULTED IN THE DEGRADATION OF THE CANNULA BODY MATERIALS. THIS DEGRADATION ALONG WITH THE RESPONSIVE STATE OF THE PATIENT, COULD HAVE CONTRIBUTED TO THE FRACTURE OF THE CANNULA. TRENDS FOR ISSUE WITH THIS PRODUCT ARE MONITORED. 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

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF A 77618 EOPA ARTERIAL CANNULA, A FRACTURE OF THE CANNULA WAS REPORTED. THE PATIENT HAD BEEN ON EXTRA CORPOREAL MEMBRANE OXYGENATION (ECMO) THERAPY FOR 12 DAYS, BEFORE A BLOOD PRESSURE ALARM DISPLAYED ON THE VITAL SIGNS MONITOR. WHEN THE NURSE ENTERED THE ROOM, THEY FOUND THE PATIENT IN PSYCHOMOTOR AGITATION, PROFUSE BLEEDING FROM THE RIGHT JUGULAR CANNULATION SITE, AND IMMEDIATE DYSFUNCTION OF ECMO THERAPY. IN THE JUGULAR AREA OF THE NECK, IT WAS FOUND THAT THE PATIENT WAS STILL CANNULATED BY THE DISTAL END OF THE ARTERIAL CANNULA. HOWEVER THE CANNULA WAS FRACTURED AND THE FIXATION SITES WERE INTEGRAL (IN THE NECK, SCALP AND SHOULDER). WHEN CHECKING THE CANNULA, A FRACTURE WAS OBSERVED IN A PORTION ANTERIOR TO THE CLAMPING AREA. ADVANCED RCCP WAS STARTED, 5 EPINEPHRINE AMPOULES, JET NOREPINEPHRINE, CRYSTALLOID RESUSCITATION AND 3 UNCROSSED BLOOD PACKETS WERE ADMINISTERED AS TREATMENT. THE PATIENT WAS WITHOUT VITAL SIGNS DESPITE RESUSCITATION MANEUVERS. THE ECMO DOCTOR ELECTED TO SUSPEND RE SUSCITATION MANEUVERS AND THE PATIENT DIED ON THE SAME DAY. THE PATIENT WAS AN ADULT PATIENT WITH A SARS-COV2 INFECTION, DUE TO ITS CLINICAL COMPLICATION, IT WAS DECIDED TO PLACE THE PATIENT ECMO THERAPY ON (B)(6)2021. ON THE (B)(6) 2021 THE PATIENT WAS IN A GLASGOW OF 15/15, WITH MOBILITY AND CONSERVED MUSCULAR STRENGTH IN THE FOUR EXTREMITIES, CONNECTED TO EXTRACORPOREAL OXYGENATING MEMBRANE ECMO VV, WITH RIGHT JUGULO-ATRIAL CANNULATION WITH AN EOPA CANNULA AND FEMORAL APPROACH VENOUS WITH ARTERIAL FEMORAL CANNULA, 3000 RPM PUMP SETTING, 4.5BPM AVERAGE CARDIAC OUTPUT, TQT WITH IMV, SNY WITH NET AND TRILUMEN CVC. THE PATIENT BECAME A LITTLE ANXIOUS AT THE BEGINNING OF THE SHIFT, WITH DIFFICULTY FALLING ASLEEP DESPITE NEUROMODULATORS AND HYPNOTICS, WITH A TENDENCY TO HYPERTENSION AND PRESENTED WITH TACHYCARDIA THAT IMPROVES AFTER THE ADMINISTRATION OF ORDERED BOLUSES OF OPIOID. THE CUSTOMER COULD NOT PROVIDE INFORMATION ON TIP OBSTRUCTION, THE CUSTOMER COULD ONLY STATE THAT THE TIP WAS FRACTURED. IT IS ASKED BUT UNKNOWN WHETHER THE CANNULA WAS HEATED OR COOLED PRIOR TO USE. THE CANNULA CAN NOT BE RETURNED DUE TO THE FACILITIES' COVID 19 PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1016440 EOPA ARTERIAL CANNULA CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS DWF PERFUSION SYSTEMS 77618 2020081214 00763000135652

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Male Death