Catalog Number 1809300-48 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Cardiac Enzyme Elevation (1838); Prolapse (2475)
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Event Date 09/09/2020 |
Event Type
Injury
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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.It should be noted that the reported patient effect of prolapse is listed in the xience skypoint, everolimus eluting coronary stent system instructions for use, as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined; however, the reported 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 of the device.The xience abt ng des 48 stent is currently not commercially available in the us; however, it is similar to a device sold in the us.
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Event Description
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Patient id: (b)(6).It was reported that on (b)(6) 2020, a percutaneous coronary intervention was performed on the mid left anterior descending (lad) coronary artery lesion.Pre-dilatation was performed and a 3.0x48mm xience stent was successfully implanted.Following, a plaque shift/disruption occurred, treated with a 3.5x15mm xience sierra stent.0% residual stenosis was observed and the event resolved without sequela.Reportedly, there was no device malfunction.No additional information was provide regarding this issue.
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Manufacturer Narrative
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A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the reported treatment appears to be related to the operational context of the procedure.C8 and c9 updated.H6: investigation findings code 114 removed.H6: investigations conclusions code 4311 removed.
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Event Description
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Subsequent to the initial / final mdr, additional information was received.Post procedure, cardiac enzymes were elevated; however, no treatment was provided.The enzyme elevation resolved one day later.No additional information was provided.
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Search Alerts/Recalls
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