BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS

    MDR report key: 14087025 · Received April 12, 2022

    Report

    Report Number
    2017233-2022-02859
    Event Type
    Injury
    Date Received
    April 12, 2022
    Date of Event
    March 17, 2022
    Report Date
    May 5, 2022
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    PRL
    PMA / PMN Number
    P160021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CBAS® HEPARIN SURFACE INCORPORATES CBAS-HEPARIN MANUFACTURED FROM HEPARIN SODIUM APL, WHICH IN COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY/NON-ELUTING.

    Additional Manufacturer Narrative · 0

    THE INFORMATION REPORTED IN THE MRN (2017233-2022-02859) HAS BEEN PREVIOUSLY REPORTED UNDER MRN (2017233-2022-02782). NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THEREFORE THIS REPORT WILL BE RETRACTED.

    Description of Event or Problem · 0

    THE FOLLOWING ARTICLE WAS REVIEWED: 'MULTIPLE CHIMNEY ENDOGRAFTS (CHEVAR) FOR RUPTURED PARARENAL AORTIC ANEURYSM' JAY JENNINGS, 1 LD SHEAHAN, 2 CC GLOSS, 2 TODD R VOGEL, 3 AND JONATHAN BATH, 3 COLUMBIA, MO. THE PATIENT IS A (B)(6) MAN WHO PRESENTED TO THE EMERGENCY DEPARTMENT AT A LOCAL HOSPITAL WITH ABDOMINAL PAIN AND HYPOTENSION. COMPUTED TOMOGRAPHY ANGIOGRAPHY (CT-A) DEMONSTRATED RUPTURED PARARENAL AAA THE PATIENT WAS STABILIZED. THE PATIENT WAS A POOR RISK FOR AN OPEN PARAVISCERAL ANEURYSM REPAIR GIVEN HIS HOME OXYGEN REQUIREMENT AND KNOWN REDUCED EJECTION FRACTION. GIVEN THE PROXIMITY OF THE ANEURYSM TO THE SUPERIOR MESENTERIC ARTERY (SMA) AND RENAL ARTERIES THE SEAL ZONE WAS PROPOSED TO BE JUST ABOVE THE CELIAC ARTERY. A 36 MM MEDTRONIC E2S (MEDTRONIC INC, MINNEAPOLIS, MN) BIFURCATED AORTIC GRAFT WAS NAVIGATED AND DEPLOYED JUST INFERIOR TO THE LEFT RENAL ARTERY ( FIG. 2 , A). GATE CANNULATION AND ILIAC LIMB EXTENSIONS WERE PERFORMED IN THE STANDARD FASHION TO COMPLETE THE ENDOGRAFT FIXATION. THROUGH THE CONTRALATERAL 14 FRENCH SHEATH ACCESS A 7 FR X 55 CM TOURGUIDE STEERABLE SHEATH (MEDTRONIC INC, (B)(6)) WAS INTRODUCED AND THE LEFT RENAL ARTERY CANNULATED WITH ADVANCEMENT OF A 7 FR X 45 CM SHEATH OVER A ROSEN WIRE (COOK MEDICAL, BLOOMINGTON, IN). IN THIS MANNER, STABLE SHEATH ACCESS WAS OBTAINED TO THE SMA AND RIGHT RENAL ARTERY IN AN ANTEGRADE (CHIMNEY) CONFIGURATION AND THE LEFT RENAL ARTERY IN A RETROGRADE (PERISCOPE) CONFIGURATION. THROUGH RIGHT FEMORAL ACCESS, A 46 × 93 MM NAVION THORACIC ENDOGRAFT (MEDTRONIC INC, MINNEAPOLIS, MN) WAS THEN NAVIGATED TO A POSITION 1 CM ABOVE THE INFRARENAL ENDOGRAFT FLOW DIVIDER ( FIG. 2 , B). THIS PROVIDED 4 CM OF OVERLAP BETWEEN THE INFRARENAL AND THE BRIDGING THORACIC ENDOGRAFT. BALLOON-EXPANDABLE COVERED STENTS (VBX, W.L.GORE & ASSOCIATES, (B)(6)) WERE THEN PLACED PARALLEL TO THE THORACIC ENDOGRAFT AND FLARED TO THE DIAMETER OF THE TARGET VESSEL. RELIANT BALLOON (MEDTRONIC INC, (B)(6)) MOLDING OF THE SEAL ZONE WAS THEN UNDERTAKEN AT THE SAME TIME AS BALLOON INFLATION OF THE VBX STENTS TO REDUCE GUTTER LEAK AND PREVENT CRUSHING OF THE VBX STENTS. COMPLETION ANGIOGRAPHY DEMONSTRATED AN ENDOLEAK THAT PERSISTED FOLLOWING SIMULTANEOUS REBALLOONING OF THE SEAL ZONE AND A DECISION WAS MADE TO REVERSE THE HEPARIN EFFECT AND MONITOR THE PATIENT CLOSELY THE PATIENT WAS DOING WELL POSTOPERATIVELY WITH MINIMAL RESUSCITATION AND A STABLE HEMOGLOBIN. ON POST-OPERATIVE DAY 2 A CT-A WAS PERFORMED AS PART OF THE POST-RUPTURED AAA PROTOCOL, DEMONSTRATING AN ENDOLEAK CAUSED BY PULLOUT OF THE BALLOON EXPANDABLE STENT FROM THE RIGHT RENAL ARTERY . THE PATIENT WAS THEN TAKEN BACK TO THE OPERATING ROOM AND THE LEFT PROXIMAL BRACHIAL ARTERY WAS SURGICALLY EXPOSED. THE RIGHT RENAL ARTERY CHIMNEY WAS CANNULATED AND THE TARGET ARTERY ORIFICE DEMONSTRATED. AN ADDITIONAL VBX STENT (W.L. GORE & ASSOCIATES, (B)(6)) WAS THEN PLACED TO SEAL INTO THE EXISTING CHIMNEY STENT WITH CLOSURE OF THE LEAK. THE PATIENT WAS DISCHARGED ON POD 5 FROM THE INITIAL RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145350 GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS ILIAC COVERED STENT, ARTERIAL PRL W. L. GORE & ASSOCIATES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other| H