BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2010797 · Received March 2, 2011

    Report

    Report Number
    2953200-2011-00581
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    April 13, 2012
    Report Date
    April 13, 2012
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (ENDOLEAK). RESULTS AND CONCLUSION: (DISEASE PROGRESSION CAUSED ANEURYSM EXPANSION).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED A TYPE I LEAK PROXIMAL AND DISTALLY. THE PHYSICIAN PLACED AN (B)(4) ANEURX TO TREAT THE LEAK IN THE LEFT ILIAC ARTERY. THE PHYSICIAN DID A FENESTRATION WITH ANOTHER MANUFACTURER'S STENT GRAFT TO TREAT THE TYPE I ENDOLEAK AT/ABOVE THE RENALS. THE PHYSICIAN STATED THERE WASN'T MUCH MIGRATION TO SPEAK OF, BUT THE PATIENT ESSENTIALLY HAD NO NECK. THE PHYSICIAN FENESTRATED THE LEFT RENAL. THERE WAS A SMALL LEAK STILL PRESENT AT THE TOP. THE PHYSICIAN WILL MONITOR THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: APPROXIMATELY THREE WEEKS AGO THE PATIENT WAS CONVERTED TO OPEN REPAIR. THE FENESTRATED DEVICE FROM ANOTHER MANUFACTURER DID NOT SEAL WELL INSIDE THE ANEURX BIFURCATED STENT GRAFT. THE PHYSICIAN STATED THAT IT WAS DIFFICULT TO REMOVE THE ANEURX ILIAC LIMBS AND THE COMMON ILIAC VEINS TORE. THE PATIENT LOST A LOT OF BLOOD BUT WAS DOING FINE ONE DAY POST OPERATIVE. THE STENT GRAFTS WERE DISCARDED BY THE USER FACILITY.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 5.0 MM X 5.4 ABDOMINAL AORTIC ANEURYSM APPROX 9.1 YEARS AGO. VESSEL MORPHOLOGY AT THIS TIME IS UNK. IT WAS REPORTED ON AN OPERATIVE REPORT 1 YEAR AGO AND A CT SCAN OF THE ABDOMEN AND PELVIS 16 MONTHS AGO, THAT THERE WAS A RIGHT COMMON ILIAC ARTERY TYPE 1 ENDOLEAK AND A TYPE III ENDOLEAK, SEPARATION OF TWO STENT GRAFT COMPONENTS, SECONDARY TO EXPANSION OF THE COMMON ILIAC ARTERY. APPROX 11 MONTHS AGO, THE RIGHT COMMON ILIAC ARTERY TYPE 1 ENDOLEAK WAS REPAIRED WITH PLACEMENT OF 2 OTHER COMPANY'S STENT GRAFTS AND THE COMPONENT SEPARATION WAS REPAIRED WITH 2 OTHER COMPANY'S STENT GRAFTS. IT WAS ALSO REPORTED THAT IN COMPARING A CT SCAN OF THE ABDOMEN AND PELVIS TAKEN 16 MONTHS AGO TO A PRIOR STUDY OF 18 MONTHS AGO, THE ANEURYSM MEASURED 7.3 X 8 CM WHERE IT WAS PREVIOUSLY 7.3 X 7.9 CM. A CT OF THE ABDOMEN AND PELVIS TAKEN 1 MONTH AGO SHOWED THAT THE ANEURYSM IS 9.1 X 7.9 CM. WITH A DISTAL TYPE 1 ENDOLEAK EXTENDING FROM THE LEFT COMMON ILIAC ARTERY, WHICH IS A NEW ENDOLEAK. THIS PT HAS A VERY SHORT SEAL ZONE AT THE RENALS AND NO ROOM FOR AN AORTIC CUFF. NO MIGRATION HAS OCCURRED. THE PHYSICIAN PLANS TO DO A FENESTRATION OF THE LEFT HYPOGASTRIC WITH A SMALL ANEURX BIFURCATED GRAFT AT AN UNK DATE. NO ADD'L CLINICAL SEQUELAE REPORTED. REF MFR 2953200-2011-00579 AND 2953200-2011-00580.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR NA M01G552132

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention