Catalog Number 1800400-23 |
Device Problems
Difficult to Remove (1528); Material Too Soft/Flexible (4007)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/01/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is estimated.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficult to remove and material too soft/flexible.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The two additional xience skypoint stents are being filed under separate medwatch report numbers.
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Event Description
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It was reported that the procedure was to treat the right coronary artery (rca).The lesion was pre-dilated with a 3 mm balloon at 18 atmospheres per standard practice.A 4.0x48 xience skypoint stent, a 4.0x23 mm xience skypoint stent and a 4.0x12 mm xience skypoint stent were implanted.Post dilatation was performed with a 5 mm balloon at 24 atmospheres.On a post market evaluation (pme) survey, the physician indicated the flexibility of the undeployed stent and ability to recapture the undeployed stent in the guiding catheter as not satisfying.Reportedly, the 4.0x12 xience skypoint sds balloon was difficult to completely deflate and there may have been an incorrect contrast ratio of 50/20.The balloon only partially deflated and was withdrawn inflated.There were no reported adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.
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Search Alerts/Recalls
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