BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT-HYDRO

    MDR report key: 1253094 · Received December 5, 2008

    Report

    Report Number
    2953200-2008-01128
    Event Type
    Injury
    Date Received
    December 5, 2008
    Date of Event
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    MEDTRONIC CARIDOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: INHERENT RISK OF PROCEDURE (ARTERIAL TRAUMA/ DISSECTION/ PERFORATION). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (SEVERLY TORTUOUS AND SEVERLY CALCIFIED VESSELS). CONCLUSION: DEVICE FAILURE/ LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (SEVERLY TORTUOUS AND SEVERLY CALCIFIED VESSELS). OTHER; SECONDARY INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. VESSEL MORPHOLOGY WAS REPORTED SEVERELY TORTUOUS AND SEVERELY CALCIFIED. DEVICE WOULD NOT ADVANCE TO THE INTENDED LANDING ZONE. IT WAS REPORTED DURING ADVANCEMENT OF THE STENT GRAFT ON THE LEFT SIDE, THE VESSEL WAS PERFORATED. THERE WAS SIGNIFICANT BLEEDING, THE PHYSICIAN ESTIMATES ABOUT 1 LITER OF BLOOD LOSS. THE PHYSICIAN REMOVED THE DELIVERY CATHETER FROM THE PATIENT. CELL SAVOR RETURNED THE BLOOD TO THE PATIENT. THE PATIENT WAS STABLE AND THE PHYSICIAN ELECTED TO ATTEMPT RE-INSERTION ON THE SAME SIDE. A 20 AND A 24 F DILATOR PASSED SUCCESSFULLY BUT NOT EASILY. ANOTHER ATTEMPT WAS MADE WITH THE DEVICE HOWEVER, UNABLE TO ADVANCE AND ELECTED TO PLACE CONDUIT. AN OBLIQUE INCISION WAS MADE ABOVE THE INGUINAL LIGAMENT AND AN END TO SIDE ANASTOMOSIS WAS MADE WITH A 10MM DACRON GRAFT. THE CONDUIT WAS ACCESSED IN THE USUAL FASHION. THE DEVICE WAS RE-ADVANCED A LITTLE HIGHER BUT WOULD STILL NOT PASS. ANOTHER ATTEMPT WAS MADE TO PUSH THE DEVICE THROUGH A DIFFICULT AREA AND THE CONDUIT AVULSED FROM THE NATIVE ARTERY. A SIGNIFICANT AMOUNT OF BLOOD WAS LOST. AN ESTIMATE OF ANOTHER LITER OF BLOOD LOSS OCCURRED. AGAIN CELL SAVOR WAS USED AND THE PATIENT WAS GIVEN 2 ADDITIONAL UNITS OF BLOOD. THE PATIENT WAS STABILIZED. BECAUSE THE PATIENT HAD REQUESTED NOT TO HAVE AN OPEN PROCEDURE, THE CASE WAS TERMINATED. REPAIRS WERE MADE TO THE ILIACS AND THE PROCEDURE WAS ENDED. NO ADDITIONAL CLINICAL SEQUELA WERE REPORTED AND THE PATIENT IS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT-HYDRO MIH MEDTRONIC CARIDOVASCULAR NA V00183760

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK