Catalog Number 1076350-15 |
Device Problems
Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/05/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.(b)(4).The xience prox is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.The device remains in the patient.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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Reportedly, a 3.50 x 15 mm xience prox stent was implanted after expiration.There was no reported clinically significant delay in the procedure and no reported adverse patient sequela.No additional information was provided.
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Manufacturer Narrative
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Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents from this lot.The investigation determined the reported information of use after expiration was use error.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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Search Alerts/Recalls
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