Catalog Number UNK XIENCE SKYPOINT |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/28/2021 |
Event Type
Injury
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Manufacturer Narrative
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The udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.It is possible that the stent was not fully apposed to the vessel wall resulting in the reported difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported patient-device incompatibility recoil cannot be determined.The treatment appears to be related to the operational context of the procedure as an unspecified stent was implanted inside the original stent and post-dilatation was performed again, resolving the issue.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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Event Description
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It was reported that the procedure was to treat an unspecified lesion.A xience skypoint was advanced to the lesion without issue.When attempting to implant the stent, the vessel pushed it back to a more recoiled position.Additional post-dilatation was performed and an additional unspecified stent was implanted overlapping.There were no adverse patient sequela and no clinically significant delay.No additional information was provided.
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Manufacturer Narrative
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The udi is unknown because the part number and lot number were not provided.The device was not returned for analysis.A review of the electronic lot history record (elhr) and similar incident query for this product was not performed because the part and lot numbers were not reported and the product was not returned for analysis.It is possible that the stent was not fully apposed to the vessel wall resulting in the reported difficulties; however this cannot be confirmed.The investigation determined a conclusive cause for the reported patient-device incompatibility recoil cannot be determined.The treatment appears to be related to the operational context of the procedure as an unspecified stent was implanted inside the original stent and post-dilatation was performed again, resolving the issue.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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Event Description
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It was reported that the procedure was to treat an unspecified lesion.A xience skypoint was advanced to the lesion without issue.When attempting to implant the stent, the vessel pushed it back to a more recoiled position.Additional post-dilatation was performed and an additional unspecified stent was implanted overlapping.There were no adverse patient sequela and no clinically significant delay.No additional information was provided.
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Search Alerts/Recalls
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