BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE VIABAHN® ENDOPROSTHESIS

    MDR report key: 5727817 · Received June 15, 2016

    Report

    Report Number
    2017233-2016-00577
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    December 6, 2011
    Report Date
    June 16, 2016
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    NIP
    PMA / PMN Number
    P040037
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GORE® VIABAHN® ENDOPROSTHESES USED IN THIS PROCEDURE DID NOT HAVE THE HEPARIN BIOACTIVE SURFACE AS STATED IN THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PXT311413/8829797, PXC181200/9500022, PXC201400/7799837, PXT231216/9472086, PAC061002/9047052, PAC061002/9047047, PAC071002/8896681, PAC071002/8896667, PAC081002/9146751, PAC081002/9146745, PAC081002/9179022, PAC061002/9179024. (B)(4) LOT: 9018650. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. THE DEVICE REMAINED IMPLANTED; CONSEQUENTLY, A DIRECT PRODUCT ANALYSIS WAS NOT POSSIBLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A PATIENT UNDERWENT ENDOVASCULAR TREATMENT FOR A THORACOABDOMINAL ANEURYSM MEASURING 54.5MM IN DIAMETER AND WAS IMPLANTED WITH GOREEXCLUDERAAA ENDOPROSTHESES IN ZONE 4 OF THE DISTAL DESCENDING THORACIC AORTA. NINE GORE VIABAHNENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE WERE ALSO IMPLANTED ENDING UP IN THE RENAL ARTERIES, CELIAC TRUNK AND SUPERIOR MESENTERIC ARTERY. THE TECHNIQUE USED FOR THIS PATIENT WAS A "TANDEM-OF-THE-SHELF" TECHNIQUE. THE PROCEDURE PERFORMED WAS NOT EXACTLY THE SAME BUT IT WAS SIMILAR. AN EXCLUDER BIFURCATED DEVICE WAS PLACED ON THE THORACIC AORTA OF THE PATIENT AND THROUGH THE CONTRALATERAL LIMB THE VIABAHN DEVICES WERE ADVANCED TO THE LEFT RENAL ARTERY, CELIAC TRUNK AND SUPERIOR MESENTERIC ARTERY. THROUGH THE LONG LIMB OF THE EXCLUDER, A VIABAHN WAS INSERTED FOR THE RIGHT RENAL ARTERY AND A EXCLUDER EXTENSION FOR THE ABDOMINAL AORTA. INSIDE OF THIS EXCLUDER EXTENSION, ANOTHER EXCLUDER BIFURCATED WAS INSERTED, WITH THE LONG LIMB FINISHING AT LEFT COMMON ILIAC ARTERY AND THE CONTRALATERAL LIMB WAS PLACED AT THE RIGHT COMMON ILIAC ARTERY IN THE DISTAL THIRD. ALMOST ALL THE EXTENSION OF THE THORACOABDOMINAL AORTA WAS COVERED INCLUDING THE EXCLUSION OF THE DISTAL THORACIC ARTERIES, ALL LUMBAR ARTERIES AND THE INFERIOR MESENTERIC ARTERY. THE PATIENT TOLERATED THE PROCEDURE, HOWEVER, IT WAS REPORTED THAT THE SAME DAY THE PATIENT EXPERIENCED PARAPLEGY AND DEVELOPED PNEUMONIA. THE PATIENT EXPIRED ON (B)(6) 2011. THE CAUSE OF DEATH WAS SEPTIC SHOCK DUE TO PNEUMONIA. THE PATIENT WOKE UP FROM ANESTHESIA THE FIRST DAY AFTER THE SURGERY AND HAD ABDOMINAL DISTENTION WITH RESPIRATORY DISTRESS, AND NEEDED TO BE RE-INTUBATED. HE DEVELOPED PNEUMONIA AND SEPTIC SHOCK AND DIED 6 DAYS FROM THE PROCEDURE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    381924 GORE VIABAHN® ENDOPROSTHESIS STENT, SUPERFICIAL FEMORAL ARTERY NIP W.L. GORE & ASSOCIATES 9018650

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Disability