H10: manufacturing review: a device history record review could not be conducted as the device lot number was not provided.Investigation summary: the lifestream device was not returned.As the stent remained in the patient, and was not returned, it could not be evaluated.Therefore, the investigation is inconclusive for the reported device adverse event.The definitive root cause for the reported device adverse event could not be determined based upon the available information received from the field communications.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: indication for use the lifestream balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Contraindications the lifestream balloon expandable vascular covered stent is contraindicated for use in: ¿ patients with uncorrected bleeding disorders ¿ patients who cannot receive recommended antiplatelet and/or anticoagulation therapy ¿ patients who are judged to have lesions that prevent complete expansion of the implant based on the lesion morphology, the diagnostic angiography and/or lesion response during pre-dilation.¿ lesions in which the lumen diameter post balloon angioplasty is insufficient for the passage of the endovascular system ¿ lesion locations subject to external compression potential adverse events potential patient/device adverse effects that may occur include, but are not limited to, the following: ¿ abscess ¿ allergic/anaphylactoid reaction ¿ amputation ¿ aneurysm / pseudoaneurysm ¿ angina/coronary ischemia ¿ arterial occlusion/thrombus, near the puncture site ¿ arterial occlusion/thrombus, remote from puncture sit ¿ arterial occlusion/restenosis of the treated vessel ¿ arteriovenous fistula ¿ arrhythmia ¿ balloon rupture ¿ blockage of major collateral artery or arterial branch ¿ bypass surgery ¿ covered stent dislodgement from balloon during tracking procedure ¿ covered stent misplacement during placement procedure ¿ covered stent migration post placement procedure ¿ covered stent insufficient wall apposition ¿ covered stent deformation / kink / fracture ¿ death ¿ distal embolization ¿ drug reaction or allergic reaction to medication, substances or materials used for the procedure (e.G.Anticoagulation or antiplatelet agent, contrast medium, stent or catheter materials) ¿ edema ¿ fever ¿ hemorrhage/bleeding ¿ hematoma and/or bleeding at puncture (access) site ¿ hypotension/hypertension ¿ inability to introduce/withdraw endovascular system ¿ inability to track endovascular system to the target lesion ¿ inability to inflate the balloon/deploy covered stent ¿ infection at access site ¿ infection at or around implant ¿ inflammation ¿ ischemia/infarction of tissue/organ ¿ myocardial infarction ¿ pain ¿ radiation injuries ¿ renal insufficiency/failure/toxicity ¿ respiratory arrest ¿ restenosis in the treatment area / covered stent edge ¿ sepsis ¿ shock ¿ stroke/transient ischemic attack (tia) ¿ thromboembolic event / thrombosis ¿ vasospasm ¿ vessel wall trauma, perforation / dissection / rupture h10: g3, h6 (method) h11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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H10: manufacturing review: a device history record review could not be conducted as the device lot number was not provided.Investigation summary: the lifestream device was not returned.As the stent remained in the patient, and was not returned, it could not be evaluated.Therefore, the investigation is inconclusive for the reported device adverse event.The definitive root cause for the reported device adverse event could not be determined based upon the available information received from the field communications.Labeling review: the instruction for use for the lifestream product was reviewed and contains the following information relevant to the reported event: indication for use: the lifestream balloon expandable vascular covered stent is indicated for the treatment of atherosclerotic lesions in common and external iliac arteries.Contraindications: the lifestream balloon expandable vascular covered stent is contraindicated for use in: ¿ patients with uncorrected bleeding disorders ¿ patients who cannot receive recommended antiplatelet and/or anticoagulation therapy ¿ patients who are judged to have lesions that prevent complete expansion of the implant based on the lesion morphology, the diagnostic angiography and/or lesion response during pre-dilation.¿ lesions in which the lumen diameter post balloon angioplasty is insufficient for the passage of the endovascular system ¿ lesion locations subject to external compression potential adverse events: potential patient/device adverse effects that may occur include, but are not limited to, the following: ¿ abscess, ¿ allergic/anaphylactoid reaction, ¿ amputation, ¿ aneurysm / pseudoaneurysm, ¿ angina/coronary ischemia, ¿ arterial occlusion/thrombus, near the puncture site, ¿ arterial occlusion/thrombus, remote from puncture sit, ¿ arterial occlusion/restenosis of the treated vessel, ¿ arteriovenous fistula, ¿ arrhythmia, ¿ balloon rupture, ¿ blockage of major collateral artery or arterial branch, ¿ bypass surgery, ¿ covered stent dislodgement from balloon during tracking procedure, ¿ covered stent misplacement during placement procedure, ¿ covered stent migration post placement procedure, ¿ covered stent insufficient wall apposition, ¿ covered stent deformation / kink / fracture, ¿ death, ¿ distal embolization, ¿ drug reaction or allergic reaction to medication, substances or materials used for the procedure (e.G.Anticoagulation or antiplatelet agent, contrast medium, stent or catheter materials), ¿ edema, ¿ fever, ¿ hemorrhage/bleeding, ¿ hematoma and/or bleeding at puncture (access) site, ¿ hypotension/hypertension, ¿ inability to introduce/withdraw endovascular system, ¿ inability to track endovascular system to the target lesion, ¿ inability to inflate the balloon/deploy covered stent, ¿ infection at access site, ¿ infection at or around implant, ¿ inflammation, ¿ ischemia/infarction of tissue/organ, ¿ myocardial infarction, ¿ pain, ¿ radiation injuries, ¿ renal insufficiency/failure/toxicity, ¿ respiratory arrest, ¿ restenosis in the treatment area / covered stent edge, ¿ sepsis, ¿ shock, ¿ stroke/transient ischemic attack (tia), ¿ thromboembolic event / thrombosis, ¿ vasospasm, ¿ vessel wall trauma, perforation / dissection / rupture.H11: section a through f ¿ the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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