Catalog Number FEL10060 |
Device Problems
Fracture (1260); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/13/2016 |
Event Type
malfunction
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Manufacturer Narrative
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The device history records are being reviewed.The event is currently under investigation.The information provided represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any patient details to date.
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Event Description
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It was reported that during deployment of the endovascular stent graft, the outer sheath of the delivery system fractured; however, the stent graft could be deployed successfully.There was no reported patient injury.
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Manufacturer Narrative
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The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.On the basis of the evaluation of the returned device, the reported event could be confirmed.The outer sheath was found to be elongated and fractured indicating the presence of high deployment force during the attempt to deploy the stent graft.The stent graft was not returned as it was successfully implanted.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may be associated with a difficult vessel anatomy leading to increased friction during deployment and subsequent sheath fracture.Insufficient flushing of the device may be another contributing factor to the reported event.On the basis of the information available, a definite root cause for the reported event could not be determined.The ifu states that the device must be flushed with sterile saline.Also the ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure." and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." furthermore, the ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device." evaluation was completed.
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Event Description
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It was reported that during deployment of the endovascular stent graft, the outer sheath of the delivery system fractured; however, the stent graft could be deployed successfully.There was no reported patient injury.
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Search Alerts/Recalls
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