Model Number S-60-080-120-P6 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Stenosis (2263)
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Event Date 12/23/2021 |
Event Type
Injury
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Event Description
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It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 80% stenosed lesion in the left popliteal artery.A 6x80 supera peripheral self-expanding stent (ses) was implanted on (b)(6) 2021, without issue.On (b)(6) 2021, the patient was re-admitted with restenosis.A 6x40mm armada 18 balloon dilatation catheter was used to treat the restenosis without issue.There was no adverse patient sequela.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 identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments appear 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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Manufacturer Narrative
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments appear 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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Event Description
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It was reported that the procedure was to treat a moderately calcified, mildly tortuous, 80% stenosed lesion in the left popliteal artery.A 6x80 supera peripheral self-expanding stent (ses) was implanted on (b)(6) 2021, without issue.On (b)(6) 2021, the patient was re-admitted with restenosis.A 6x40mm armada 18 balloon dilatation catheter was used to treat the restenosis without issue.There was no adverse patient sequela.No additional information was provided.
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Search Alerts/Recalls
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