Date of implant ¿ estimated.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 investigation was unable to determine a conclusive cause for the reported defective device (shortened); however, factors that may contribute to defective device (shortened) include, but are not limited to, processing and/or handling in manufacturing, handling during preparation for use, lesion characteristics, procedural technique, product size selection, severe torquing or kinking of stent (material stress/ fatigue) or interaction with the accessory devices, lesion and/or anatomy.It is possible that interactions with the anatomy resulted in shortening of the stent and/or user perception/inaccurate measuring under fluoroscopy may have resulted in difficulties visualizing the stent; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.
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It was reported that approximately 6 months ago a 4.0x28mm xience skypoint stent was successfully implanted in the vertebral artery.On (b)(6) 2023, the patient underwent a routine follow up, and it was discovered through imaging that the stent had a compressed/shortened area.There was no harm to the patient.The stent is patent and the patient has no symptoms with no treatment being administered at this time.The patient was sent home.No additional information was provided.
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