Catalog Number 1500350-28 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problems
Occlusion (1984); Prolapse (2475)
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Event Date 02/26/2020 |
Event Type
Injury
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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.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The reported patient effects of prolapse and occlusion are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported wall apposition; however, factors that may contribute to patient-device incompatibility (wall apposition) include, but are not limited to, interaction with insufficient post-dilation, incorrect device size for lesion, patient anatomical morphology, and patient disease state.The reported patient effects of prolapse, occlusion and additional therapy/non-surgical treatment appear to be related to operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The other xience sierra device referenced is filed under a separate medwatch report number.
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Event Description
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Patient id: (b)(6).It was reported that on (b)(6) 2020, the patient underwent a coronary procedure, performed to treat a lesion in the mid left anterior descending (lad) artery.Two xience sierra stents, a 3.5 x 23 mm and a 3.5 x 28 mm, were implanted.During implantation of the 3.5 x 23 mm xience sierra stent, the second diagonal artery was lost.Additionally, stent malapposition and plaque shift occurred with both implanted stents.Edge dissection was noted at the distal stent, the 3.5 x 23 mm xience sierra.Additional balloon dilatation was performed to treat the adverse patient effects and the event resolved on (b)(6) 2020.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.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of prolapse and occlusion are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as known patient effects of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported wall apposition; however, factors that may contribute to patient-device incompatibility (wall apposition) include, but are not limited to, interaction with insufficient post-dilation, incorrect device size for lesion, patient anatomical morphology, and patient disease state.The reported patient effects of prolapse, occlusion and additional therapy/non-surgical treatment appear to be related to 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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