BEUDAMED
    FDA Adverse Event Death Summary report: N

    MANTA 14F

    MDR report key: 14803740 · Received June 24, 2022

    Report

    Report Number
    3010252479-2022-00273
    Event Type
    Death
    Date Received
    June 24, 2022
    Date of Event
    June 1, 2022
    Report Date
    June 6, 2022
    Manufacturer
    ESSENTIAL MEDICAL, INC
    Product Code
    MGB
    UDI-DI
    00856279007079
    PMA / PMN Number
    P180025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF DEVICE HISTORY RECORDS WILL BE CONDUCTED. A FOLLOW-UP REPORT WILL BE ISSUED AFTER THE INVESTIGAITON IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. NO RETURN PRODUCT EVALUATION COULD BE COMPLETED. THE DEVICE LOT HISTORY RECORD REVIEW INDICATED NO NON-CONFORMITIES REPORTED RELATED TO THIS LOT, THEREFORE, SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS PRIOR TO SHIPMENT. BASED ON THE INFORMATION SUBMITTED, THE PATIENT WAS A SHOCK PATIENT TRANSFER FROM AN AFFILIATE HOSPITAL. FOLLOWING A PERCUTANEOUS VENTRICULAR ASSIST DEVICE (PVAD) REMOVAL, A 14F MANTA WAS PLANNED FOR CLOSURE IN THE RIGHT FEMORAL ARTERY. A CENTRAL POSITIONED ACCESS WAS ACHIEVED; HOWEVER, DIFFICULTIES WERE ENCOUNTERED WHILE ATTEMPTING TO GAIN DEPTH MEASUREMENT; BLOOD WAS EXITING THE DEPTH LOCATOR. THE IFU WARNS DO NOT USE MANTA IF THERE IS SUBSTANTIAL BLEEDING AROUND THE DEPTH LOCATOR AT THE ACCESS SITE DURING THE DEPTH LOCATION PROCEDURE, AS THIS MAY RESULT IN AN INACCURATE MEASUREMENT. ADDITIONALLY, IN STEP 1: ARTERIOTOMY LOCATION PROCEDURE: NOTE: IF THERE IS BLEEDING VISUALIZED AROUND THE DEPTH LOCATOR, THE MEASUREMENT MAY BE INACCURATE DUE TO THE ACCESS SITE BEING TOO LARGE. DO NOT PROCEED WITH MANTA CLOSURE. THE PHYSICIAN PLACED A 12F SHEATH AND TOOK AN ANGIOGRAM OF THE RCFA WHICH INDICATED SLUGGISH FLOW AND NO OBSTRUCTION. THE PHYSICIAN EXCHANGED THE 12F SHEATH FOR THE MANTA DEPTH LOCATOR; AND WAS ABLE TO OBTAIN A MEASUREMENT OF 3.5CM + 1CM. THE ARTERIOTOMY WAS >5MM, NO CALCIFICATION OR TORTUOSITY PRESENT. FOLLOWING DEPLOYMENT, A SUCCESSFUL CLOSURE WITH NO ACTIVE BLEEDING IMMEDIATELY POST DEPLOYMENT OF MANTA. HEMOSTASIS WAS IMMEDIATE; AND DOPPLER IMAGES INDICATED DISTAL PULSES PRESENT. APPROXIMATELY ONE WEEK LATER POST-CLOSURE IN THE ICU, THE PATIENT HAD EXPIRED, HOWEVER, THE CAUSE OF DEATH IS UNKNOWN AT THIS TIME. THE PROCTOR REACHED OUT TO THE PHYSICIAN FOR FURTHER INFORMATION. THE PHYSICIAN INDICATED HE DOES NOT THINK THE DEATH HAD ANYTHING TO DO WITH THE ACCESS SITE OR THE MANTA DEVICE. THE IFU LISTS THE FOLLOWING POTENTIAL ADVERSE EVENTS RELATED TO THE DEPLOYMENT OF VASCULAR CLOSURE DEVICES INCLUDE OTHER ACCESS SITE COMPLICATIONS LEADING TO BLEEDING, HEMATOMA, PSEUDOANEURYSM, OR ARTERIO-VENOUS FISTULA, POSSIBLY REQUIRING BLOOD TRANSFUSION, SURGICAL REPAIR, AND/OR ENDOVASCULAR INTERVENTION. POTENTIAL ADVERSE EVENTS ASSOCIATED WITH ANY LARGE BORE INTERVENTION, INCLUDING THE USE OF THE MANTA VASCULAR CLOSURE DEVICE, INCLUDE BUT ARE NOT LIMITED TO: DEATH RELATED TO THE PROCEDURE, AND OOZING FROM THE PUNCTURE SITE.

    Description of Event or Problem · 0

    AS REPORTED: MANTA WAS DEPLOYED, AND SOME POINT THE PATIENT PASSED AFTER DEPLOYMENT. THE CAUSE OF DEATH IS UNKNOWN TO US AT THE TIME. THERE WAS NO ACTIVE BLEEDING NOTED IMMEDIATELY POST DEPLOYMENT OF DEVICE. ADDITIONAL INFORMATION ON 10 JUN 2022: PATIENT WAS A SHOCK PATIENT TRANSFER FROM A SISTER HOSPITAL. AT THE TIME OF DEVICE USED FOR TEMPORARY VENTRICULAR SUPPORT, ACT WAS 135. WHEN ATTEMPTING TO GAIN DEPTH MEASUREMENT, HAD SOME DIFFICULTIES WITH THE BLOOD COMING-OUT FROM THE DEPTH LOCATOR. THE DOCTOR THEN TOOK A 12 FR SHEATH AND TOOK A RIGHT FEMORAL ANGIO TO SEE WHAT WAS GOING ON. THERE WAS SOME SLUGGISH FLOW BUT NO OBSTRUCTION OF THE RFA. THE DOCTOR THEN EXCHANGED THE SHEATH FOR THE 14 FR (DEVICE LOCATOR) AND GOT A DEPTH OF 3.5 CM +1 SO WE DEPLOYED AT 4.5 CM. THE CLOSURE WAS A SUCCESS WITH INSTANT HEMOSTASIS AND THERE WHERE DISTAL PULSES WITH DOPPLER. AFTER KNOWLEDGE, THAT THE PATIENT HAD EXPIRED, ASKED THE DOCTOR IF THE EVENT THAT HAPPENED IN THE ICU POST CLOSURE HAD ANYTHING TO DO WITH MANTA AND HE STATED, NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890004 MANTA 14F VASCULAR CLOSURE DEVICE MGB ESSENTIAL MEDICAL, INC 2156 MN2101428 00856279007079

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death