Catalog Number FVL08080 |
Device Problems
Positioning Failure (1158); Fracture (1260); Material Perforation (2205)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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The device has not been returned for evaluation; therefore, the investigation is inconclusive for the failure to deploy and fracture as no objective evidence has been provided to confirm any alleged deficiency with the vascular stent graft.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model fvl08080 vascular stent graft allegedly experienced a failure to deploy and a fracture.This information was received from a single source.The alleged failure to deploy and fracture involved a patient with no known impact to the patient.The patient is a (b)(6) -year-old male, weighing (b)(6) kg.
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Event Description
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This report summarizes one malfunction.A review of the reported information indicated that model fvl08080 vascular stent graft allegedly experienced a failure to deploy, a fracture, material perforation, and partial deployment.This information was received from a single source.The alleged malfunction involved a patient with no known impact to the patient.The patient is a 79-year-old male, weighing 63kg.
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Manufacturer Narrative
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H10: the lot number for the malfunction was provided and a lot history review was performed.The device was not returned for evaluation.However, based on a photo provided, it was confirmed that a strut perforated the distal end of the delivery systems catheter proximal to the marker which prevented complete deployment of the stent graft.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.H10: b5; g4; h6 (device 2532- misfire).H11: g1; h6 (method, results).H11:section a through f - the information provided by bd represents all of 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.
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Search Alerts/Recalls
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