Catalog Number UNK RX SIERRA |
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 06/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Date of event has been estimated.The udi number is unknown as the catalog number and lot number were not provided.Implant date has been estimated.The stent remains in patient.The device will not be returned for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the procedure was to treat an unspecified artery.The xience sierra stent was implanted but had a proximal recoil after implantation.The stent recoil was resolved by placing another stent.There was no adverse patient effect and there was no reported clinically significant delay in the procedure.No additional information was provided.
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Manufacturer Narrative
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The device was not returned for analysis.The lot history record (lhr) for this product could not be reviewed and a similar complaint query of the complaint handling system could not be performed because the product was not returned for evaluation and the part and lot numbers were not reported.The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (recoil); however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
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Search Alerts/Recalls
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