BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERA 3000

    MDR report key: 18104003 · Received November 9, 2023

    Report

    Report Number
    3015537318-2023-00042
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    December 25, 2022
    Report Date
    November 13, 2023
    Manufacturer
    INTERA ONCOLOGY
    Product Code
    LKK
    UDI-DI
    00850014110147
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED EXACT INCIDENT DATE AND PATIENT INFORMATION BASED ON HCP FOLLOW UP COMMUNICATIONS.

    Additional Manufacturer Narrative · 0

    PSEUDOANEURYSM IS A KNOWN ADVERSE EVENT AS LISTED ON THE LABELING OF THE INTERA 3000. IMPLANT AND EXPLANT DATES DETERMINED VIA INTERA IMPLANT TRACKING PROCESS, BUT EXACT INCIDENT DATE NOT PROVIDED IN THE LITERATURE SOURCE. IF FURTHER INFORMATION IS RECEIVED AT A LATER DATE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    LITERATURE CITATION: SNEH BRAHMBHATT, LUIS F. ACOSTA, GABY GABRIEL, DRISS RAISSI. RECURRENT HEPATIC ARTERY PSEUDOANEURYSM REPAIR WITH OVERLAPPING TAPERED STENT-GRAFT TECHNIQUE. RADIOLOGY CASE REPORTS, VOLUME 18, ISSUE 12, 2023, PAGES 4537-4543, ISSN 1930-0433, HTTPS://DOI.ORG/10.1016/J.RADCR.2023.09.038. ABSTRACT: HEPATIC ARTERY PSEUDOANEURYSMS (HAPS) ARE RARE BUT LIFE-THREATENING COMPLICATIONS ASSOCIATED WITH HEPATIC ARTERY INFUSION PUMP (HAIP) THERAPY FOR UNRESECTABLE LIVER METASTASES. TRADITIONAL MANAGEMENT OPTIONS INCLUDE OPEN SURGERY OR STENT PLACEMENT, BUT THESE APPROACHES HAVE DRAWBACKS. WE PRESENT A UNIQUE CASE OF A DISLODGED STENT EMBEDDED IN A HAP, RESULTING IN DELAYED TYPE-I ENDOLEAK. TO ADDRESS THIS, WE EMPLOYED A NOVEL TECHNIQUE USING MULTIPLE OVERLAPPING TAPERED STENTS TO RECONSTRUCT THE HEPATIC ARTERY. THIS APPROACH SUCCESSFULLY EXCLUDED THE PSEUDOANEURYSM WITHOUT ENDOLEAK. STENT-GRAFT PLACEMENT EMERGES AS A SAFER AND MORE EFFECTIVE OPTION FOR MANAGING HAP, PRESERVING HEPATIC ARTERIAL FLOW, AND REDUCING MORBIDITY COMPARED TO OTHER METHODS. HOWEVER, FURTHER RESEARCH IS NEEDED TO EVALUATE THIS TECHNIQUE'S LONG-TERM OUTCOMES AND POTENTIAL COMPLICATIONS.

    Description of Event or Problem · 0

    LITERATURE CITATION: SNEH BRAHMBHATT, LUIS F. ACOSTA, GABY GABRIEL, DRISS RAISSI. RECURRENT HEPATIC ARTERY PSEUDOANEURYSM REPAIR WITH OVERLAPPING TAPERED STENT-GRAFT TECHNIQUE. RADIOLOGY CASE REPORTS, VOLUME 18, ISSUE 12, 2023, PAGES 4537-4543, ISSN 1930-0433, HTTPS://DOI.ORG/10.1016/J.RADCR.2023.09.038. ABSTRACT: HEPATIC ARTERY PSEUDOANEURYSMS (HAPS) ARE RARE BUT LIFE-THREATENING COMPLICATIONS ASSOCIATED WITH HEPATIC ARTERY INFUSION PUMP (HAIP) THERAPY FOR UNRESECTABLE LIVER METASTASES. TRADITIONAL MANAGEMENT OPTIONS INCLUDE OPEN SURGERY OR STENT PLACEMENT, BUT THESE APPROACHES HAVE DRAWBACKS. WE PRESENT A UNIQUE CASE OF A DISLODGED STENT EMBEDDED IN A HAP, RESULTING IN DELAYED TYPE-I ENDOLEAK. TO ADDRESS THIS, WE EMPLOYED A NOVEL TECHNIQUE USING MULTIPLE OVERLAPPING TAPERED STENTS TO RECONSTRUCT THE HEPATIC ARTERY. THIS APPROACH SUCCESSFULLY EXCLUDED THE PSEUDOANEURYSM WITHOUT ENDOLEAK. STENT-GRAFT PLACEMENT EMERGES AS A SAFER AND MORE EFFECTIVE OPTION FOR MANAGING HAP, PRESERVING HEPATIC ARTERIAL FLOW, AND REDUCING MORBIDITY COMPARED TO OTHER METHODS. HOWEVER, FURTHER RESEARCH IS NEEDED TO EVALUATE THIS TECHNIQUE'S LONG-TERM OUTCOMES AND POTENTIAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110899 INTERA 3000 HEPATIC ARTERY INFUSION PUMP LKK INTERA ONCOLOGY AP03000H 28724 00850014110147

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention