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Model Number C07100SL |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Reocclusion (1985); Vascular System (Circulation), Impaired (2572)
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Event Date 09/09/2016 |
Event Type
Injury
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Manufacturer Narrative
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As reported by the smart pms for superficial femoral artery (sfa) study, two smart control stents (iliac 8x40, and iliac 7x100) were implanted in the target lesion without any issue.Approximately three years later, the patient started to feel pain in the left lower leg.Within a month, revascularization was performed in the target lesion due to in-stent restenosis.The patient has recovered.The patient¿s information was unknown.The target lesion was the proximal region of the left femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.No additional information is available.The product was not returned for analysis.A device history record (dhr) review of lot 15642001 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.In-stent restenosis is a well-known potential complication for this type of procedural and it listed in the ifu.In the literature, in-stent stenosis rates from 11% to 39% from 6 to 12 months after the stent placement.Rates are higher in older patient with more severe atherosclerosis and depended on the type of stenosis treated.Stenosis in stents are usually treated with intrastent pta or placement of a second stent.Progression of atherosclerotic disease is known to cause instent restenosis and does not indicate a device failure.Intra-arterial stent placement is a treatment of the disease process and it is not a preventive or cure for the progression of symptoms of atherosclerotic artery disease.There is no evidence of manufacturing issues that may have contributed to the reported event therefore; no corrective action is required at this time.There are patient and lesion characteristics that may have contributed to the reported event, specifically the risk factors for atherosclerotic disease.Should additional information become available, the file will be updated accordingly.
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Event Description
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As reported by the smart pms for superficial femoral artery (sfa) study, two smart control stents (iliac 8x40, and iliac 7x100) were implanted in the target lesion without any issue.Approximately three years later, the patient started to feel pain in the left lower leg.Within a month, revascularization was performed in the target lesion due to in-stent restenosis.The patient has recovered.The patient¿s information was unknown.The target lesion was the proximal region of the left femoral artery.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.
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Search Alerts/Recalls
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