Catalog Number LSMU1351258 |
Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/21/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Photos were provided to the manufacturer for review.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date 11/2021).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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Event Description
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It was reported that during a market demonstration, the balloon expandable vascular covered stent was inflated to 10atm when the eptfe allegedly split.There was no patient contact.
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Event Description
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It was reported that during a market demonstration, the balloon expandable vascular covered stent was inflated to 10atm when the eptfe allegedly split.There was no patient contact.
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Manufacturer Narrative
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H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the investigation is confirmed for the reported material split issue.The sample and photos were returned for analysis.It is unknown if other procedural or handling techniques contributed to the reported event.Labeling review: the ifu for the lifestream product was reviewed and contains the following information relevant to the reported event: the event description states that the lifestream device was being used for a market demonstration outside of the patient.This is off label use of the device.The lifestream stent is intended only in the treatment of atherosclerotic lesions in the common and external iliac arteries.H10: d4 (expiry date 11/2021).
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Search Alerts/Recalls
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