Catalog Number 1011708-15 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Angina (1710); Stenosis (2263)
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Event Date 04/03/2023 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
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Event Description
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It was reported that the procedure was to treat a de novo lesion in the left anterior descending (lad) with 90% stenosis, mild calcification and moderate tortuosity.On (b)(6) 2022, the 2.75x15mm xience prime stent was implanted.However, on (b)(6) 2023 on follow-up, in-stent restenosis was found in the stented artery because the patient presented with angina.The patient was transferred to a different hospital where the treatment was performed but type of treatment was not specified.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.No additional information was provided.
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Event Description
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It was reported that the procedure was to treat a de novo lesion in the left anterior descending (lad) with 90% stenosis, mild calcification and moderate tortuosity.On 12/07/2022, the 2.75x15mm xience prime stent was implanted.However, on 04/03/2023 on follow-up, in-stent restenosis was found in the stented artery.There was no adverse patient sequelae and there was no clinically significant delay in the procedure.Subsequent to the initial report filed, the following information was provided: the patient presented with angina and was transferred to a different hospital where treatment was performed but cannot be specified.No additional information was provided.
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Manufacturer Narrative
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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.The reported patient effects of angina and stenosis are listed in the xience prime, xience prime small vessel (sv), and xience prime long length (ll), everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; 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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