GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS
Report
- Report Number
- 2017233-2024-04931
- Event Type
- Injury
- Date Received
- May 15, 2024
- Date of Event
- May 6, 2024
- Report Date
- January 15, 2025
- Manufacturer
- W. L. GORE & ASSOCIATES, INC.
- Product Code
- PRL
- PMA / PMN Number
- P160021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO PATIENT SPECIFIC DETAILS HAVE BEEN PROVIDED. THEREFORE, THE PATIENT INITIALS REFLECT THE W. L. GORE INTERNAL CASE NUMBER. C1: CBAS® HEPARIN SURFACE INCORPORATES CARMEDA HEPARIN MANUFACTURED FROM HEPARIN SODIUM API, WHICH IS COVALENTLY BOUND TO THE DEVICE SURFACE AND IS ESSENTIALLY NON-ELUTING. H3: CODE ¿OTHER¿ WAS SELECTED AS NO DEVICE INFORMATION (SERIAL OR LOT NUMBER) IS AVAILABLE AND NO DEVICE WAS RETURNED. W. L. GORE & ASSOCIATES, INC. (GORE) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY GORE, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. BLANK FIELDS PRESENT ON THIS REPORT INCLUDE REQUIRED FIELDS AND FIELDS DETERMINED TO BE NOT APPLICABLE. BLANK REQUIRED FIELDS INDICATE THAT THE INFORMATION WAS NOT PROVIDED, WAS DEEMED UNAVAILABLE OR WAS NOT APPLICABLE. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, GORE, OR ITS ASSOCIATES THAT THE DEVICE, GORE OR ITS ASSOCIATES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE A LEGAL ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY DEFECTS OR HAS MALFUNCTIONED, AS DEFINED FROM A LEGAL STANDPOINT. THESE WORDS ARE INCLUDED IN THE REPORT AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.
THREE-DIMENSIONAL GEOMETRIC ANALYSIS OF VIABAHN VBX BRIDGING STENT GRAFTS IN FENESTRATED ENDOVASCULAR AORTIC REPAIR: A MULTICENTER, RETROSPECTIVE COHORT STUDY - FATIMA FOUAD, BEN R. SALEEM, IGNACE F. J. TIELLIU, MATTEO A. PEGORER, RAFFAELLO BELLOSTA, DAVIDE ESPOSITO, AARON T. FARGION, CLARK J. ZEEBREGTS, JEAN-PAUL P. M. DE VRIES, RICHTE C. L. SCHUURMANN, 2024. DOI: 10.1177/1526602824124860. FURTHER EVALUATION OF THE LITERATURE SHOWED THAT THE REPORTED UNSUCCESSFUL STENTING OF THE CELIAC TRUNK IN THREE PATIENTS COULD BE TRACED TO MISALIGNMENT OF THE COOK FENESTRATED STENT GRAFT WITH THE TARGET ARTERY IN 2 PATIENTS AND TO UNFAVORABLE ANATOMICAL CONDITIONS IN ONE PATIENT. THE AVAILABLE INFORMATION REPORTED IN THE COMPLAINT DOES NOT REASONABLY SUGGEST A POTENTIAL MALFUNCTION OR PRODUCT PACKAGING AND/OR LABELING ISSUE HAS OCCURRED NOR DOES IT MEET CRITERIA OF A REPORTABLE SERIOUS INJURY, THEREFORE THIS COMPLAINT WILL BE SWITCHED TO A NON-REPORTABLE COMPLAINT AND ALL INITIALLY SUBMITTED REPORTS WILL BE RETRACTED. EMDR SECTION H6 CODES UPDATED TO REFLECT RESULTS OF INVESTIGATION.
THREE-DIMENSIONAL GEOMETRIC ANALYSIS OF VIABAHN VBX BRIDGING STENT GRAFTS IN FENESTRATED ENDOVASCULAR AORTIC REPAIR: A MULTICENTER, RETROSPECTIVE COHORT STUDY - FATIMA FOUAD, BEN R. SALEEM, IGNACE F. J. TIELLIU, MATTEO A. PEGORER, RAFFAELLO BELLOSTA, DAVIDE ESPOSITO, AARON T. FARGION, CLARK J. ZEEBREGTS, JEAN-PAUL P. M. DE VRIES, RICHTE C. L. SCHUURMANN, 2024 DOI: 10.1177/1526602824124860. SUMMARY: THIS STUDY INCLUDED 43 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 73 YEARS WHO UNDERWENT FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) BETWEEN 2018 AND 2022 IN 3 VASCULAR CENTERS PARTICIPATING IN THE GORE VIABAHN VBX BALLOON-EXPANDABLE COVERED STENT (VBX) EXPAND REGISTRY. THE THREE-DIMENSIONAL FLARE GEOMETRY OF THE GORE VIABAHN VBX BECS WAS ASSESSED ON THE FIRST AND SECOND POSTOPERATIVE CTA SCANS, AND GEOMETRICAL CHANGES DURING THIS PERIOD WERE IDENTIFIED. A CUSTOM-MADE COOK ZENITH FENESTRATED STENT GRAFT WAS USED IN ALL CASES. THE VBX SIZES USED VARIED BASED ON ANATOMY. TECHNICAL SUCCESS WAS DEFINED AS SUCCESSFUL DEPLOYMENT OF THE PLANNED FENESTRATED STENT GRAFT AND BECS(S) WITH PATENT TARGET VESSEL(S) AND ABSENCE OF TYPE 1 OR 3 ENDOLEAKS ON COMPLETION ANGIOGRAPHY. TECHNICAL FAILURE IN 3 PATIENTS (7%) WAS CAUSED BY UNSUCCESSFUL STENTING OF THE CTR, 2 CASES DUE TO MISALIGNMENT OF THE VBX AND THE FENESTRATED STENT GRAFT WITH THE TARGET ARTERY AND 1 DUE TO A SHARP ANGULATION OF THE CTR RELATIVE TO THE AORTIC CENTER LUMEN LINE. THE FENESTRATIONS IN THESE 3 PATIENTS WERE LEFT OPEN DUE TO THE LONG SEAL ZONE. AN UNCOMPLICATED COURSE WAS OBSERVED IN 87 BECS (97%). BALLOON-EXPANDABLE COVERED STENT-RELATED COMPLICATIONS WERE REPORTED IN 3 VBX STENTS (2 LEFT RENAL ARTERIES AND 1 CELIAC TRUNK) DURING A MEDIAN FOLLOW-UP (FU) OF 14 MONTHS. ONE VBX IN THE LEFT RENAL ARTERY (LRA) SHOWED A TYPE 3C ENDOLEAK AFTER 14 MONTHS, WHICH WAS CLASSIFIED AS E1 (INSUFFICIENT FLARE) USING VAN DER RIET¿S CLASSIFICATION. ON THE FIRST POSTOPERATIVE CTA SCAN, THE FLARE-TO-FENESTRATION DISTANCE (FFD) WAS ALREADY INSUFFICIENT (0.2 MM). THROUGH A COMMON FEMORAL ARTERY ACCESS THE LRA WAS CANNULATED AFTER WHICH A VBX WAS DEPLOYED AND FLARED. THIS RELINING WAS PERFORMED 15 MONTHS AFTER THE INDEX PROCEDURE. AT 5 YEARS FU, THE BECS REMAINED PATENT. TWO VBX STENTS OCCLUDED. ONE OCCLUDED VBX IN THE CELIAC TRUNK (CTR), REPORTED AFTER 36 DAYS ON FU1, WAS CLASSIFIED AS O1, O3, OR O4 (FLARE COMPRESSION/MISALIGNMENT WITH THE TARGET ARTERY AND/OR NONGEOMETRIC CAUSE). THE COMPLICATION WAS ASYMPTOMATIC, SO NO REINTERVENTION WAS PERFORMED. ANOTHER OCCLUSION IN THE LRA WAS REPORTED AFTER 14 MONTHS (FU2) AND CLASSIFIED AS O1 AND F2 (FRACTURED AND COMPRESSED FLARE). THE STENT FRACTURE WITH A D-RATIO OF 0.59 WAS IN RETROSPECT ALREADY VISIBLE ON FU1. THERE WAS NO PLANNED REINTERVENTION BECAUSE OF OLD AGE, SO CONSEQUENTLY, THERE WAS ATROPHY OF THE LEFT KIDNEY, BUT A FUNCTIONAL RIGHT KIDNEY REMAINED. THIS STUDY SHOWED 93% OF THE VBX BECS USED HAD AN UNEVENTFUL FU WITH STABLE FLARE GEOMETRY AND APPOSITION WITH THE TARGET ARTERY. FURTHERMORE, THIS STUDY SHOWED THAT MOST OF THE 3-DIMENSIONAL FLARE GEOMETRY OF THE VBX DID NOT CHANGE SIGNIFICANTLY DURING 1-YEAR OF FU. A SMALL BUT SIGNIFICANT CHANGE WAS FOUND FOR THE FLARE ANGLE THAT MAY BE THE RESULT FROM CONTINUED ADAPTATION TO TARGET VESSEL ANATOMY. ALTHOUGH THE AIM OF THIS STUDY WAS NOT TO COMPARE FLARE GEOMETRY OF THE 3 COMPLICATED BECS WITH NONCOMPLICATED BECS, DEVIATIONS FROM NORMAL GEOMETRY WERE CLEARLY OBSERVED FOR THE 3 COMPLICATED BECS. ONE PATIENT EXPERIENCED A TYPE 3C ENDOLEAK THAT WAS MOST LIKELY CAUSED BY A SHORT FFD. ANOTHER PATIENT WITH A BECS OCCLUSION HAD A VERY LONG FFD, WHICH COULD BE A RISK FACTOR FOR IN-STENT OCCLUSION. IN THE THIRD PATIENT, A CRUSHED FLARE WAS RETROSPECTIVELY DETECTED ON THE FIRST POSTOPERATIVE CTA SCAN WITH THE HELP OF GEOMETRIC ANALYSIS, WHEREAS THE ACTUAL OCCLUSION WAS OBSERVED ONLY ON THE 1-YEAR FU CT, AND CONSEQUENTLY THE KIDNEY COULD NO LONGER BE SAVED.
THREE-DIMENSIONAL GEOMETRIC ANALYSIS OF VIABAHN VBX BRIDGING STENT GRAFTS IN FENESTRATED ENDOVASCULAR AORTIC REPAIR: A MULTICENTER, RETROSPECTIVE COHORT STUDY - FATIMA FOUAD, BEN R. SALEEM, IGNACE F. J. TIELLIU, MATTEO A. PEGORER, RAFFAELLO BELLOSTA, DAVIDE ESPOSITO, AARON T. FARGION, CLARK J. ZEEBREGTS, JEAN-PAUL P. M. DE VRIES, RICHTE C. L. SCHUURMANN, 2024. DOI: 10.1177/1526602824124860. SUMMARY: THIS STUDY INCLUDED 43 PREDOMINANTLY MALE PATIENTS WITH A MEAN AGE OF 73 YEARS WHO UNDERWENT FENESTRATED ENDOVASCULAR AORTIC REPAIR (FEVAR) BETWEEN 2018 AND 2022 IN 3 VASCULAR CENTERS PARTICIPATING IN THE GORE VIABAHN VBX BALLOON-EXPANDABLE COVERED STENT (VBX DEVICE) EXPAND REGISTRY. THE THREE-DIMENSIONAL FLARE GEOMETRY OF THE GORE VIABAHN VBX DEVICE BALLOON EXPANDABLE COVERED STENT (BECS) WAS ASSESSED ON THE FIRST AND SECOND POSTOPERATIVE CTA SCANS, AND GEOMETRICAL CHANGES DURING THIS PERIOD WERE IDENTIFIED. A CUSTOM-MADE COOK ZENITH FENESTRATED STENT GRAFT WAS USED IN ALL CASES. THE VBX DEVICE SIZES USED VARIED BASED ON ANATOMY. TECHNICAL FAILURE IN 3 PATIENTS (7%) WAS CAUSED BY UNSUCCESSFUL STENTING OF THE CELIAC TRUNK (CTR), 2 CASES DUE TO MISALIGNMENT OF THE VBX DEVICES(S) AND THE FENESTRATED STENT GRAFT WITH THE TARGET ARTERY AND 1 DUE TO A SHARP ANGULATION OF THE CTR RELATIVE TO THE AORTIC CENTER LUMEN LINE. THE FENESTRATIONS IN THESE 3 PATIENTS WERE LEFT OPEN DUE TO THE LONG SEAL ZONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1547914 | GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS | ILIAC COVERED STENT, ARTERIAL | PRL | W. L. GORE & ASSOCIATES, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |