MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. LIFESTREAM; BALLOON EXPANDABLE VASCULAR COVERED STENT

Model Number	LSMU0800938
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
Event or Problem Description
It was reported that during a stent placement procedure in the external iliac and after using a minx, the blood pressure of the patient allegedly started to drop ultimately leading to the death of the patient.
Event or Problem Description
It was reported that during a stent placement procedure in the external iliac and after using a mynx closure device, the blood pressure of the patient allegedly started to drop ultimately leading to the death of the patient.
Additional Manufacturer Narrative
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 indication 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.H3 other text : device not returned.
Additional Manufacturer Narrative
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 indication 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.H3 other text : device not returned.
Event or Problem Description
It was reported that during a stent placement procedure in the external iliac and after using a mynx closure device, the blood pressure of the patient allegedly started to drop ultimately leading to the death of the patient.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review could not be conducted as the device lot number was no 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.Labeling review: the instruction for use or 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.Device not returned.
Event or Problem Description
It was reported that during a stent placement procedure in the external iliac and after using a mynx closure device, the blood pressure of the patient allegedly started to drop ultimately leading to the death of the patient.The patient death was not related to the product malfunction.

• Brand Name: LIFESTREAM
• Common Device Name: BALLOON EXPANDABLE VASCULAR COVERED STENT
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12622391
• Report Number: 9616666-2021-00163
• Device Sequence Number: 4380791
• Product Code: PRL
• UDI-Device Identifier: 05391522081246
• UDI-Public: (01)05391522081246
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P160024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 12/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LSMU0800938
• Device Catalogue Number: LSMU0800938
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 11/25/2021; 12/03/2021; 12/15/2021
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 11/30/2021; 12/04/2021; 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Sex: Female
• Patient Race: White