Model Number VBJR050702A |
Device Problems
Break (1069); Entrapment of Device (1212); Malposition of Device (2616); Device Damaged by Another Device (2915)
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Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/28/2022 |
Event Type
Injury
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Manufacturer Narrative
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Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Results of device evaluation are pending completion of investigation and will be provided in final report.
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Event Description
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It was reported to gore that during a in stent restenosis (isr) procedure the gore® viabahn® endoprosthesis with heparin bioactive surface was unable to be deployed due to deployment line break.Reportedly the physician was unable to pull the device back into the sheath nor were they able to remove the device from the patient.It was reported that the patient was transferred to a local hospital to remove the device.Reportedly patient status is unknown at this time nor the outcome of the procedure.Per the fsa, patient was transported to local hospital ((b)(6) hospital center).Upon which the surgeon observed that the undeployed gore® viabahn® endoprosthesis with heparin bioactive surface stent was caught on the original stent strut (manufacturer unknown), this was why the stent was unable to be removed when deployment failed.Reportedly once vsx was pulled free, the vsx deployed and was removed successfully.It was reported that the procedure was completed with another gore vsx device and the patient tolerated the procedure.
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Manufacturer Narrative
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The reported device failure mode, deployment line breaks, was confirmed during physical examination of the returned device.The cause of the device failure mode could not be determined.The complaint reports the vsx device was caught on the existing stent during attempted removal.It is not known how long the existing stent had been implanted, and a relationship between the broken deployment line and the existing stent could not be established.
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Event Description
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It was reported to gore that during a in stent restenosis (isr) procedure the gore® viabahn® endoprosthesis with heparin bioactive surface was unable to be deployed due to deployment line break.Reportedly the physician was unable to pull the device back into the sheath nor were they able to remove the device from the patient.It was reported that the patient was transferred to a local hospital to remove the device.Reportedly patient status is unknown at this time nor the outcome of the procedure.Per the fsa, patient was transported to local hospital (b)(6) hospital).Upon which the surgeon observed that the undeployed gore® viabahn® endoprosthesis with heparin bioactive surface stent was caught on the original stent strut (manufacturer unknown), this was why the stent was unable to be removed when deployment failed.Reportedly, once vsx was pulled free, the device deployed.However, it unintentionally covered the profunda.It was reported that the procedure was completed with another gore vsx device to treat the originally intended lesion.At a later date, the physician performed a follow-up procedure and uncovered the profunda successfully.The patient tolerated all interventional procedures.
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Manufacturer Narrative
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Revised the description of event with the additional information received from the field.
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Event Description
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It was reported to gore that during a in stent restenosis (isr) procedure the gore® viabahn® endoprosthesis with heparin bioactive surface was unable to be deployed due to deployment line break.Reportedly the physician was unable to pull the device back into the sheath nor were they able to remove the device from the patient.It was reported that the patient was transferred to a local hospital to remove the device.Reportedly patient status is unknown at this time nor the outcome of the procedure.Per the fsa, patient was transported to local hospital (washington hospital center).Upon which the surgeon observed that the undeployed gore® viabahn® endoprosthesis with heparin bioactive surface stent was caught on the original stent strut (manufacturer unknown), this was why the stent was unable to be removed when deployment failed.Reportedly once vsx was pulled free, the vsx deployed successfully covering the profunda.It was reported that the procedure was completed with another gore vsx device and the patient tolerated the procedure.
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Manufacturer Narrative
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This report is being sent to include the additional information received from the field.
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Search Alerts/Recalls
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