It was reported in (b)(6) 2020, a 3x48mm xience xpedition drug eluting stent (des) was implanted to treat a lesion in the mildly calcified, mildly tortuous right coronary artery (rca) on (b)(6) 2022, the patient presented with discomfort and imaging was performed, which revealed that the stent was separated into two pieces.A 3x12mm non-abbott stent was implanted to cover the separated stent, without issue.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
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Date of implant: 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 similar incidents from this lot.The reported patient effect of pain is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.A cine was received and reviewed by an abbott vascular clinical specialist: the reviewer concluded that the provided images confirm the reported event, but no probable cause can be determined.The investigation was unable to determine a conclusive cause for the reported material separation; however, factors that could contribute to material separation include, but are not limited to, interaction with accessory devices, over expansion of the stent, deployment technique, and/or anatomical characteristics.Based on the information provided it is unknown what may have caused the reported material separation.Additionally, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined; however, the subsequent 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.The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.
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