BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENVEO PRO DELIVERY SYSTEM

    MDR report key: 11717393 · Received April 23, 2021

    Report

    Report Number
    2025587-2021-01227
    Event Type
    Injury
    Date Received
    April 23, 2021
    Date of Event
    December 16, 2020
    Report Date
    April 23, 2021
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    NPT
    PMA / PMN Number
    P130021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ABU-MUCH A, ET AL. DON¿T TRUST THE IMAGING: NECROTIC BOWEL FOLLOWING TRANSCATHETER AORTIC VALVE REPLACEMENT THROUGH AORTIC STENT GRAFT. JACC: CASE REPORTS. (B)(6) 2020; 2(15): 2339-2343. DOI: 10.1016/J.JACCAS.2020.10.023. AVAILABLE ONLINE 16 (B)(6) 2020. EARLIEST DATE OF PUBLISH USED FOR DATE OF EVENT. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION FROM A LITERATURE CASE REPORT REGARDING AN (B)(6) YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY OF PERIPHERAL VASCULAR DISEASE, INCLUDING ABDOMINAL AORTIC ANEURYSM TREATED WITH ENDOVASCULAR REPAIR USING A STENT GRAFT EXTENDING FROM BELOW THE RENAL ARTERIES TO BOTH COMMON ILIAC ARTERIES; END-STAGE RENAL FAILURE TREATED WITH HEMODIALYSIS; AND A HISTORY OF HEAVY SMOKING. THE PATIENT UNDERWENT TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) VIA THE RIGHT FEMORAL APPROACH WITH A 34 MM MEDTRONIC EVOLUT PRO VALVE SYSTEM. THE AUTHORS STATED THERE WERE NO DIFFICULTIES IN ADVANCING THE ENVEO PRO DELIVERY CATHETER SYSTEM (DCS) THROUGH THE PATIENT¿S AORTIC STENT GRAFT. DURING THE PROCEDURE, THE PATIENT DEVELOPED NEW LEFT BUNDLE BRANCH BLOCK. NO TREATMENT WAS REPORTED AS A RESULT. IN THE POST-OPERATIVE RECOVERY UNIT, THE PATIENT REPORTED VAGUE AND MILD LOWER BACK PAIN. TWO HOURS LATER, THE PAIN EXACERBATED AND REQUIRED ANALGESICS. THE PATIENT LOCALIZED HIS PAIN TO THE LOWER ABDOMEN. URGENT ABDOMINOPELVIC COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED AND SHOWED NO EVIDENCE OF AORTIC DISSECTION, RETROPERITONEAL BLEEDING, OR OCCLUSION IN ABDOMINOPELVIC AORTIC BRANCHES, BUT DID REVEAL A NEW SPLENIC INFARCT. SUBSEQUENTLY, THE PATIENT WAS TREATED CONSERVATIVELY WITH REHYDRATION AND ANALGESICS AS NEEDED. THE FOLLOWING DAY, THE PATIENT REPORTED PAIN IMPROVEMENT, BUT AGAIN DESCRIBED ABDOMINAL PAIN, WITH FURTHER LOCALIZATION TO THE RIGHT UPPER AND LOWER ABDOMEN. A POINT-OF-CARE ASSESSMENT SHOWED A DISTENDED ABDOMEN. REPEAT ABDOMINOPELVIC COMPUTED TOMOGRAPHY ANGIOGRAPHY WAS PERFORMED, WHICH SHOWED NO EVIDENCE OF VASCULAR OCCLUSION IN THE MESENTERIC ARTERIES OR SIGNS OF BOWEL ISCHEMIA. CONSIDERING THE WORSENING ABDOMINAL PAIN, ALONG WITH MARKED ELEVATION OF INFLAMMATORY MARKERS, AN EXPLORATORY LAPAROTOMY WAS PERFORMED, WHICH REVEALED A NECROTIC SMALL BOWEL AND A GANGRENOUS GALLBLADDER. CONSEQUENTLY, THE PATIENT UNDERWENT CHOLECYSTECTOMY, SMALL BOWEL RESECTION, AND DIVERTING ILEOSTOMY. FOLLOWING THE SURGERY, THE PATIENT WAS DISCHARGED TO THE SURGICAL WARD AFTER A ONE-WEEK STAY IN THE INTENSIVE CARE UNIT AND WAS AWAITING TRANSFER TO A REHABILITATION UNIT. THE AUTHORS DID NOT PROVIDE AN EXACT CAUSE OF THE SPLENIC INFARCT BUT SUGGESTED THAT ADVANCING THE DCS VIA THE RETROGRADE FEMORAL APPROACH THROUGH THE AORTIC STENT GRAFT COULD HAVE DISLODGED EXISTING MURAL THROMBUS AND TISSUE DEBRIS. NO UNIQUE DEVICE IDENTIFIER NUMBERS WERE PROVIDED. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613043 ENVEO PRO DELIVERY SYSTEM AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT MEDTRONIC HEART VALVES DIVISION ENVPRO-16 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R