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Common name = stent, superficial femoral artery, drug-eluting.Pro code = niu.Occupation = unspecified health care professional.Pma/510(k) number = p100022.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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It was reported a (b)(6) male underwent an endovascular procedure of the left popliteal artery on (b)(6) 2018 as part of a clinical study utilizing two (2) zilver paclitaxel-eluting peripheral stents.One hundred ninety days post procedure it was reported the patient was diagnosed with ectasia and "positive remodeling" within the study lesion.The study lesion was in the left distal superficial femoral artery (sfa) and popliteal artery, 130 mm in length.There was 100 percent stenosis in the study lesion noted on baseline angiography.The proximal reference vessel diameter (rvd) was 6.0 mm.The distal rvd was 6.0 mm.Pre-stent dilatation was performed with four inflations of a 4 mm x 60 mm balloon, one inflation of a 6 mm x 100 mm balloon and two inflations of a 6 mm x 80 mm balloon.The access site was contralateral.Two study stents were placed without difficulty.Post stent dilatation was performed with two inflations of a 6 mm x 135 mm balloon.Final angiography measurements revealed twenty percent diameter stenosis in the study lesion.The patient was discharged on (b)(6) 2018.Discharge medications were aspirin and clopidogrel.One hundred ninety (190) days post-procedure, the patient was admitted to the hospital for an unrelated event involving the left great toe: ¿advanced 'phlegmone' digit 1 and lymphangitis left leg,¿ resulting from a fracture of the left great toe three weeks prior.The patient underwent a study follow-up angiography on the day of admission and was diagnosed with ¿ektasia¿ of the treated segment.The maximum lumen diameter estimated was ten (10) mm and a doppler ultrasound was performed for verification.No treatment was provided.The stents remain in-situ.The study stents did not exhibit a deterioration in character or performance.No malfunction was alleged.Although requested, no additional information regarding treatment has been provided.The study physician has been queried for additional information on what is meant by "positive remodeling" but none has been received to date.The unrelated toe injury is reportedly now worsening with increasing infection signs.The study investigator indicated the infection was not related to the study device or procedure.The infection progressed to ¿lymphangitis up to the groin left leg¿ which was treated with antibiotics.The study investigator indicated the lymphangitis was not related to the study device or procedure and the study device did not malfunction.The study site has not provided the date of discharge from the hospital; however, the patient remains in the study.
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Correction: lot: cf1313207.Investigation - evaluation: reviews of the complaint history, device history record, documentation, instructions for use (ifu), manufacturer¿s instructions, and quality control of the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, imaging was provided and reviewed.The impression of this review is as follows: popliteal artery (pa) ectasia beyond the stents at six months is confirmed.The ectasia however was secondary to reabsorption of the heavily calcified atheroma and not aneurysmal dilation.Pre-angioplasty adventitial perfusion confirms a preexisting pa aneurysm.A pre-existing pa aneurysm also correlates with the above knee pa location (p1 segment), absence of significant disease elsewhere, the initial peri-adventitial artery location, and the slightly s-curving p1 segment.Although drug induced atheroma reabsorption cannot be excluded, plaque reabsorption distal the stents suggests a different etiology.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record shows no nonconforming events which could contribute to this failure mode.It should also be noted there were no other reported complaints for this lot number.Furthermore, an ifu is provided with this device which states all necessary instructions, warnings, indications, contraindications, warnings, and precautions.There is no evidence to suggest this document was not followed.Per the imaging review, it is possible that this event was attributed to the reabsorption of the heavily calcified atheroma.According to the initial reporter, a doppler ultrasound was performed for verification.Ectasia is often attributed atherosclerosis, coronary artery disease, some connective tissue disorders, and vasculitis.It can also be congenital.Based on current information, this clinical assessment cannot eliminate medical procedure or disease progression as related causes.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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