MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Aneurysm (1708); Vascular Dissection (3160); Thrombosis/Thrombus (4440)

Event Date 11/29/2022

Event Type  Injury  

Event Description

Eminent clinical study it was reported there was in-stent thrombosis.The subject was enrolled in the eminent study on (b)(6) 2020 and the index procedure was performed on the same day.The target lesion was located in left distal superficial femoral (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of 6 mm x 120 mm study stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2020, the subject was discharged.On (b)(6) 2022, 1042 days post index procedure, the subject presented with an unknown symptom and was diagnosed with stent occlusion.On (b)(6) 2022, the subject was hospitalized for further evaluation and treatment.This event led to the prolongation of the hospitalization.The subject underwent thrombolysis, and angiography without revascularization was performed as a treatment for this event.On (b)(6) 2022, the subject was discharged.

Manufacturer Narrative

B5: describe event or problem: additional information.H6: impact code: removed hospitalization or prolonged hospitalization code.

Event Description

Eminent clinical study.It was reported there was in-stent thrombosis.The subject was enrolled in the eminent study on 22-jan-2020 and the index procedure was performed on the same day.The target lesion was located in left distal superficial femoral (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of 6 mm x 120 mm study stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2020, the subject was discharged.On 29-nov-2022, 1042 days post index procedure, the subject presented with an unknown symptom and was diagnosed with stent occlusion.On 06-dec-2022, the subject was hospitalized for further evaluation and treatment.This event led to the prolongation of the hospitalization.The subject underwent thrombolysis, and angiography without revascularization was performed as a treatment for this event.On 10-dec-2022, the subject was discharged.It was further reported that on 29-nov-2022, 1042 days post index procedure, the subject presented with stent occlusion in left sfa proximal to the stent.Based upon symptoms, the subject was recommended to undergo an interventional procedure as a treatment for this event.On 06-dec-2022, 1049 days post index procedure, treatment of the thrombus was performed in the left proximal sfa (non-target lesion).Post procedure, no thrombus was seen.On 09-dec-2022, the event was recovered/resolved.

Manufacturer Narrative

B5: describe event or problem: additional information.

Event Description

Eminent clinical study.It was reported there was in-stent thrombosis.The subject was enrolled in the eminent study on 22-jan-2020 and the index procedure was performed on the same day.The target lesion was located in left distal superficial femoral (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of 6 mm x 120 mm study stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2020, the subject was discharged.On (b)(6) 2022 1042 days post index procedure, the subject presented with an unknown symptom and was diagnosed with stent occlusion.On (b)(6) 2022 the subject was hospitalized for further evaluation and treatment.This event led to the prolongation of the hospitalization.The subject underwent thrombolysis, and angiography without revascularization was performed as a treatment for this event.On (b)(6) 2022 the subject was discharged.It was further reported that on (b)(6) 2022 1042 days post index procedure, the subject presented with stent occlusion in left sfa proximal to the stent.Based upon symptoms, the subject was recommended to undergo an interventional procedure as a treatment for this event.On (b)(6) 2022 1049 days post index procedure, treatment of the thrombus was performed in the left proximal sfa (non-target lesion).Post procedure, no thrombus was seen.On (b)(6) 2022 the event was recovered/resolved.It was further reported that on (b)(6) 2022 1042 days post index procedure, the subject presented with ischemic rest pain in the left foot.On (b)(6) 2022 1049 days post index procedure, to treat thrombus in the left proximal sfa (non-target lesion), thrombolysis was performed as a treatment in intensive care.Post procedure, full resolution of thrombus and no thrombus was seen with good clinical picture.The event resulted in a life-threatening illness or injury.On (b)(6) 2022 the event was considered to be recovered/resolved.On (b)(6) 2022 the subject was discharged in good general health.

Manufacturer Narrative

B5: describe event or problem: additional information.

Event Description

Eminent clinical study.It was reported there was in-stent thrombosis.The subject was enrolled in the eminent study on 22-jan-2020 and the index procedure was performed on the same day.The target lesion was located in left distal superficial femoral (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of 6 mm x 120 mm study stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2020, the subject was discharged.On (b)(6) 2022 1042 days post index procedure, the subject presented with an unknown symptom and was diagnosed with stent occlusion.On (b)(6) 2022 the subject was hospitalized for further evaluation and treatment.This event led to the prolongation of the hospitalization.The subject underwent thrombolysis, and angiography without revascularization was performed as a treatment for this event.On (b)(6) 2022 the subject was discharged.It was further reported that on (b)(6) 2022 1042 days post index procedure, the subject presented with stent occlusion in left sfa proximal to the stent.Based upon symptoms, the subject was recommended to undergo an interventional procedure as a treatment for this event.On (b)(6) 2022 1049 days post index procedure, treatment of the thrombus was performed in the left proximal sfa (non-target lesion).Post procedure, no thrombus was seen.On (b)(6) 2022 the event was recovered/resolved.It was further reported that on (b)(6) 2022 1042 days post index procedure, the subject presented with ischemic rest pain in the left foot.On (b)(6) 2022 1049 days post index procedure, to treat thrombus in the left proximal sfa (non-target lesion), thrombolysis was performed as a treatment in intensive care.Post procedure, full resolution of thrombus and no thrombus was seen with good clinical picture.The event resulted in a life-threatening illness or injury.On (b)(6) 2022 the event was considered to be recovered/resolved.On (b)(6) 2022 the subject was discharged in good general health.It was further reported that on (b)(6) 2022 1042 days post index procedure, the subject was suffering from a cold and painful left foot which gets better while hanging leg.The subject was on asaflow and sintrom medication during the event.On arrival to the emergency department, the subject was awake and alert with swelling and pitting edema in left lower leg.Pulsation was not assessable also capacitance-resistance (cr) delay was noticed.On (b)(6) 2022 1049 days post index procedure, left proximal sfa (non-target lesion) with 100% stenosis with 18 mm long and a reference vessel diameter of 4.5 mm, was treated by performing thrombolysis as a treatment in intensive care.Post procedure, resulted in 20% of residual stenosis.

Event Description

Eminent clinical study.It was reported there was in-stent thrombosis.The subject was enrolled in the eminent study on 22-jan-2020 and the index procedure was performed on the same day.The target lesion was located in left distal superficial femoral (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 5mm and distal reference vessel diameter of 5 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of 6 mm x 120 mm study stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2020 , the subject was discharged.On (b)(6) 2023 1042 days post index procedure, the subject presented with an unknown symptom and was diagnosed with stent occlusion.On 06-dec-2022, the subject was hospitalized for further evaluation and treatment.This event led to the prolongation of the hospitalization.The subject underwent thrombolysis, and angiography without revascularization was performed as a treatment for this event.On (b)(6) 2022 the subject was discharged.It was further reported that on (b)(6) 2022 , 1042 days post index procedure, the subject presented with stent occlusion in left sfa proximal to the stent.Based upon symptoms, the subject was recommended to undergo an interventional procedure as a treatment for this event.On (b)(6) 2022 1049 days post index procedure, treatment of the thrombus was performed in the left proximal sfa (non-target lesion).Post procedure, no thrombus was seen.On (b)(6) 2022 the event was recovered/resolved.It was further reported that on (b)(6) 2022 1042 days post index procedure, the subject presented with ischemic rest pain in the left foot.On (b)(6) 2022 1049 days post index procedure, to treat thrombus in the left proximal sfa (non-target lesion), thrombolysis was performed as a treatment in intensive care.Post procedure, full resolution of thrombus and no thrombus was seen with good clinical picture.The event resulted in a life-threatening illness or injury.On (b)(6) 2022 the event was considered to be recovered/resolved.On (b)(6) 2022 the subject was discharged in good general health.It was further reported that on (b)(6) 2022 1042 days post index procedure, the subject was suffering from a cold and painful left foot which gets better while hanging leg.The subject was on asaflow and sintrom medication during the event.On arrival to the emergency department, the subject was awake and alert with swelling and pitting edema in left lower leg.Pulsation was not assessable also capacitance-resistance (cr) delay was noticed.On (b)(6) 2022 1049 days post index procedure, left proximal sfa (non-target lesion) with 100% stenosis with 18 mm long and a reference vessel diameter of 4.5 mm, was treated by performing thrombolysis as a treatment in intensive care.Post procedure, resulted in 20% of residual stenosis.It was further reported that on (b)(6) 2022 1042 days post index procedure, the subject experienced sudden onset of pain in the left foot which has progressively increased with unbearable pain even at rest which gets better while hanging leg and difficulty in walking.On (b)(6) 2022 clinical examination showed the left foot was cooler than the right and deep pink in color with no edema.Preserved sensibility and delayed in capillary refill.On (b)(6) 2022 1049 days post index procedure, left proximal sfa (non-target lesion) with 100% stenosis with 18 mm long and a reference vessel diameter of 4.5 mm, was treated by performing thrombolysis as a treatment in intensive care with heparinization via peripheral venous infusion of 1000 iu per hour, with regular activated partial thromboplastin time (aptt) checks in every 4 hours, possibly every 2 hours for severely abnormal values it must be between 60-80 aptt value.First 2 hours 4,000 iu/min, then continue at 2,000 iu/min with first perform check on fibrinogen 2 hours after starting.After that every 4 hours or rapidly in case of severely abnormal values.If fibrinogen is less than 100, stop actosolv.On (b)(6) 2022 angiography showed good lysis.However, proximal in the stent was still thrombosed.Distal from the stent an expansion of the popliteal artery was visible, and dissection was suspected with ectasia.The catheter was pulled back a few cm and thrombolysis were continued.On (b)(6) 2022 in the context of monitoring with thrombolysis sheet was removed and angiography showed improved images.On 09-dec-2022, recommended to discontinue urokinase treatment.On (b)(6) 2022 restart 80 mg asaflow and 1 mg sintrom medication.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16134009
• MDR Text Key: 307039089
• Report Number: 2124215-2022-56105
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022768645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Race: White