W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® VBX BALLOON EXPANDABLE ENDOPROSTHESIS; ILIAC COVERED STENT, ARTERIAL
|
Back to Search Results |
|
Catalog Number BXA072902A |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 10/31/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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.
|
|
Event Description
|
The following information was reported to gore: on (b)(6) 2023, a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) was intended for use in the iliac artery during treatment of a severely calcified artery.During the advancement of the introducer sheath (manufacturer and size unknown), it had become stuck and would not advance through the severely calcified lesion.The physician then attempted to advance the vbx device through the calcified lesion and it had become stuck.During the advancement of the vbx device, it appeared to be dislodging from the delivery catheter.With some manipulation, the physician was able to get the vbx device back into the introducer sheath and remove them in tandem.The physician advanced a new introducer sheath (manufacturer and size unknown) and performed an angioplasty.A new vbx device (same size) was implanted to complete the procedure.The patient did not experience any adverse consequences.
|
|
Manufacturer Narrative
|
Section h6 updated to reflect completion of investigation.A review of the manufacturing records indicated the device lots met all pre-release manufacturing specifications.The device was not returned for an engineering evaluation, therefore, not available for analysis.No clinical images enabling direct assessment of product performance were returned for evaluation.Cause of the reported event cannot be established based on the information reported to gore.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.
|
|
Search Alerts/Recalls
|
|
|