BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREO ABDOMINAL STENT-GRAFT SYSTEM

    MDR report key: 10505645 · Received September 8, 2020

    Report

    Report Number
    2247858-2020-00040
    Event Type
    Injury
    Date Received
    September 8, 2020
    Date of Event
    August 11, 2020
    Report Date
    October 5, 2020
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P190015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 0

    "AFTER IMPLANTATION OF TREO BIFURCATE DEVICE AND TWO TREO ILIAC LIMB DEVICES, AN ANGIOGRAM REVEALED A PINHOLE STREAM OF CONTRAST EMANATING FROM THE RIGHT ILIAC LIMB. BALLOONING DID NOT RESOLVE THE PINHOLE STREAM OF CONTRAST. A SECOND TREO ILIAC CLIMB WAS PLACED WITHIN THE INITIAL TREO ILIAC LIMB (THE ILIAC LIMB WAS "RELINED"). THIS RESOLVED THE PINHOLE JET OF CONTRAST. THERE WAS NO HARM TO THE PATIENT. EMAIL RECEIVED FROM (B)(6) ON 08/21/2020: "THE TREO MAIN BODY AND TREO LIMBS HAD BEEN DEPLOYED IN THE STANDARD FASHION. THE SURGEON DID A FINAL ANGIOGRAM WHICH SHOWED A T3 ENDOLEAK, APPEARING TO EMANATE FROM ONE OF THE ILIAC LIMBS. MORE BALLOONING WAS DONE WITH THE MDT RELIANT ( WHICH HAD BEEN USED PREVIOUSLY TO BALLOON THE ENTIRETY OF THE TREO MAIN BODY AND LIMBS). ANOTHER ANGIOGRAM SHOWED A VERY DISTINCT JET OF CONTRAST EMANATING FROM ONE AREA IN THE RIGHT ILIAC LIMB, JUST BELOW THE OVERLAP ZONE (OVERLAP WITH THE MAIN BODY). THE JET WAS SENDING CONTRAST INTO THE ANEURYSM SAC. THE SURGEON DECIDED THAT THERE WAS A PINHOLE TEAR OR LEAK IN THE RIGHT ILIAC LIMB, AND THEN RELINED THE RIGHT ILIAC LIMB WITH ANOTHER TREO ILIAC LIMB ( 9 X 120). A FINAL ANGIOGRAM WAS DONE AND THE JET OF CONTRAST HAD RESOLVED. NO CONTRAST FLOWED ONTO THE SAC OF THE ANEURYSM." PATIENT OUTCOME: "NO PATIENT INJURY WAS CAUSED."

    Additional Manufacturer Narrative · 1

    THE TREO ABDOMICAL STENT GRAFT SYSTEM RECEIVED FDA APPROVAL FOR SALE IN THE US ON MAY 4, 2020 (P190015).

    Description of Event or Problem · 1

    "AFTER IMPLANTATION OF TREO BIFURCATE DEVICE AND TWO TREO ILIAC LIMB DEVICES, AN ANGIOGRAM REVEALED A PINHOLE STREAM OF CONTRAST EMANATING FROM THE RIGHT ILIAC LIMB. BALLOONING DID NOT RESOLVE THE PINHOLE STREAM OF CONTRAST. A SECOND TREO ILIAC CLIMB WAS PLACED WITHIN THE INITIAL TREO ILIAC LIMB (THE ILIAC LIMB WAS "RELINED"). THIS RESOLVED THE PINHOLE JET OF CONTRAST. THERE WAS NO HARM TO THE PATIENT. EMAIL RECEIVED FROM (B)(6) ON (B)(6) 2020: "THE TREO MAIN BODY AND TREO LIMBS HAD BEEN DEPLOYED IN THE STANDARD FASHION. THE SURGEON DID A FINAL ANGIOGRAM WHICH SHOWED A T3 ENDOLEAK, APPEARING TO EMANATE FROM ONE OF THE ILIAC LIMBS. MORE BALLOONING WAS DONE WITH THE MDT RELIANT ( WHICH HAD BEEN USED PREVIOUSLY TO BALLOON THE ENTIRETY OF THE TREO MAIN BODY AND LIMBS). ANOTHER ANGIOGRAM SHOWED A VERY DISTINCT JET OF CONTRAST EMANATING FROM ONE AREA IN THE RIGHT ILIAC LIMB, JUST BELOW THE OVERLAP ZONE (OVERLAP WITH THE MAIN BODY). THE JET WAS SENDING CONTRAST INTO THE ANEURYSM SAC. THE SURGEON DECIDED THAT THERE WAS A PINHOLE TEAR OR LEAK IN THE RIGHT ILIAC LIMB, AND THEN RELINED THE RIGHT ILIAC LIMB WITH ANOTHER TREO ILIAC LIMB ( 9 X 120). A FINAL ANGIOGRAM WAS DONE AND THE JET OF CONTRAST HAD RESOLVED. NO CONTRAST FLOWED ONTO THE SAC OF THE ANEURYSM." PATIENT OUTCOME: "NO PATIENT INJURY WAS CAUSED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    965620 TREO ABDOMINAL STENT-GRAFT SYSTEM STENT, ENDOVASCUALR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2006290198

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other| R