Catalog Number LSM1350737 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
No Consequences Or Impact To Patient (2199); Injury (2348)
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Event Date 02/26/2019 |
Event Type
Injury
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Manufacturer Narrative
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As the lot number for the device was not provided, a manufacturing review could not be 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.The catalog number identified has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stent products are identified.
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Event Description
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It was reported that during deployment the stent graft allegedly dislodged from the delivery system.There was no reported patient injury.
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Manufacturer Narrative
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As the lot number for the device was not provided, a manufacturing review could not be 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.The catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestream balloon expandable vascular covered stent products that are cleared in the us.The 510 k number and pro code for the lifestream balloon expandable vascular covered stent products are identified in d2 and g5.
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Event Description
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It was reported that during a stent graft placement in the left femoral artery via right femoral artery access, during deployment the stent graft allegedly dislodged from the delivery system.Reportedly, the device was surgically retrieved and successfully implanted.The current patient status is unknown.
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Search Alerts/Recalls
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