Estimated dates.The device was not returned for evaluation.A review of the lot history record of the reported device could not be conducted because the lot number was not provided.The reported patient effects of pseudoaneurysm and angina is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.However, the 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 3.0x33 mm xience xpedition stent referenced is filed under a separate medwatch report number.
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It was reported in a research article that the procedure was to treat multi-vessel disease.For treatment of the mid left anterior descending (lad), pre-dilatation was performed and a 3.0x33 mm xience xpedition stent was implanted at the proximal part.Because of residual stenosis in the mid part, another 2.5x18 mm xience xpedition stent was implanted.The patient was discharged in good condition.Six weeks later, the patient experienced chest pain and angiography showed a pseudoaneurysm in the mid portion of the lad at the site of the previous stenting.Bypass graft surgery was performed to resolve the pseudoaneurysm and treat the patient's coronary artery disease.No additional information was provided.For full details, see attached article titled: "a case report of a coronary artery aneurysm as a rare complication of percutaneous coronary intervention.".
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