Catalog Number UNK RX SIERRA |
Device Problem
Difficult or Delayed Positioning (1157)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: date is estimated.The device location was not provided, and it is unknown if the device is returning for analysis.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 as a general comment that the physician feels that the xience sierra stent delivery system has poor visibility under the x-ray.Therefore, the physician prefers a non-abbott stent.There were no adverse patient effects and no 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 evaluation.A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot numbers were not provided.The investigation was unable to determine a conclusive cause for the reported difficulty positioning (poor visibility during fluoroscopy).There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.The udi is unknown because the part and lot #s were not provided.
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Search Alerts/Recalls
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