Catalog Number FVL14100 |
Device Problems
Difficult or Delayed Positioning (1157); Positioning Failure (1158); Malposition of Device (2616)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2023 |
Event Type
malfunction
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Event Description
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It was reported that a stent graft was difficult to deploy, which occurred during the attempt to place two stent grafts during the same procedure.The delivery system of this stent graft was properly flushed.As reported, the y-adapter got disconnected from the delivery catheter.The stent graft was deployed after much effort but misplaced due to proximal migration.There was no reported patient injury.
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Manufacturer Narrative
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The catalog number identified has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified.As the lot number for the device was provided, a review of the device history records is currently being performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiration date: 04/2025.The information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.Device not returned.
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Event Description
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It was reported that a stent graft could not be deployed in the patient.This occurred during the attempt to place two stent grafts during the same procedure.The delivery system of this stent graft was properly flushed.There was no reported patient injury.
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Manufacturer Narrative
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H10: additional information was received, and the file was reassessed for reportability, and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the catalog number identified in section d4 has not been cleared in the us but is similar to the fluency plus endovascular stent graft that are cleared in the us.The pro code and 510 k number for the fluency plus endovascular stent graft are identified in d2 and g4.H10: d4 (expiration date: 04/2025), g3 h11: b5, h6 (device) h11: section a through f ¿ the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.
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Search Alerts/Recalls
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