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 Necrosis (1971); Pain (1994); Obstruction/Occlusion (2422); Swelling/ Edema (4577)

Event Date 05/11/2023

Event Type  Injury  

Event Description

Eminent (b)(6).It was reported that stent occlusion occurred, and the patient underwent interventional procedure to treat the event.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in left mid superficial femoral artery (sfa) with 100% stenosis.The lesion was 60 mm long with a proximal reference vessel diameter of 4 mm, a distal reference vessel diameter of 4 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 stents.Following post dilation, the residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet medications.On (b)(6) 2023, 1535 days post index procedure, the subject was diagnosed with fontaine stage 4 pavd (peripheral arterial vascular disease) due to the stent occlusion of left sfa.The subject was recommended for 2.5 mg ascal/rivarox twice per day.On (b)(6) 2023, duplex imaging showed severe plaque formation origin left sfa and stenosis 75-99%, psv ratio 10.1 and calcified trajectory, followed by occlusion.Also, occlusion of stent left sfa up to distal and substantial plaque formation in left popliteal artery and especially distal very narrow patent lumen popliteal artery.On (b)(6) 2023, the subject revisited due to pain at rest and night.Physical examination showed digit v defect of left foot.The subject was advised to continue for 2.5 mg ascal/rivarox twice per day and 20 mg rosuvastatin per day.On (b)(6) 2023, 1568 days post index procedure, the subject was hospitalized for planned treatment and evaluation.On the basis of symptoms and diagnostics finding, the subject was diagnosed with fontaine stage 3 paod (peripheral arterial occlusive disease) due to gangrene and stenosis of femoral- artery on the left.The pre-marked great saphenous vein (gsv) was released and removed with multiple incisions.Tunnel was made with the tunneler device behind the condylar block along with the sartorius.Then, groin was clamped and arteriotomy was done followed by thromboendarterectomy (tea).Suturing was reversed of gsv with prolene 6.0.Tunneling was done under 2 phases; pressure followed by clamps on the popliteal artery and arteriotomy was performed with custom bypass.Back flow from the lower leg reasonable was noticed finally and stitching of bypass prolene 6.0 was done.During procedure, the subject had 300 ml blood loss; however, no blood transfusion was required.Postoperative treatment showed good pulsations across the bypass and all wounds were closed in layers.On (b)(6) 2023, the subject was discharged home in good condition and was recommended to start fraxiparine and continued ascal, clopidogrel, and 2.5 mg rivaroxaban twice a day.On the same day, the subject was readmitted for observation after bleeding and for digit v wound checkup on the left.Physical examination showed left leg supple, and calf had some edema, left foot was warm with good sensory motor skills and digit v necrotic wound was not moist on the left.On (b)(6) 2023, the subject was discharged and was advised to restart diuretics and rinse toe once per day and apply dry dressing.

Manufacturer Narrative

A1 - patient identifier: study id (b)(6).A2 - age at time of event: the subject was 65 years old at the time of study enrollment.

Manufacturer Narrative

A1 - patient identifier: study id (b)(6).A2 - age at time of event: the subject was 65 years old at the time of study enrollment.Updated field: b5 - describe event or problem.

Event Description

Eminent (b)(6).It was reported that stent occlusion occurred, and the patient underwent interventional procedure to treat the event.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in left mid superficial femoral artery (sfa) with 100% stenosis.The lesion was 60 mm long with a proximal reference vessel diameter of 4 mm, a distal reference vessel diameter of 4 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 stents.Following post dilation, the residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet medications.On (b)(6) 2023, 1535 days post index procedure, the subject was diagnosed with fontaine stage 4 pavd (peripheral arterial vascular disease) due to the stent occlusion of left sfa.The subject was recommended for 2.5 mg ascal/rivarox twice per day.On (b)(6) 2023, duplex imaging showed severe plaque formation origin left sfa and stenosis 75-99%, psv ratio 10.1 and calcified trajectory, followed by occlusion.Also, occlusion of stent left sfa up to distal and substantial plaque formation in left popliteal artery and especially distal very narrow patent lumen popliteal artery.On (b)(6) 2023, the subject revisited due to pain at rest and night.Physical examination showed digit v defect of left foot.The subject was advised to continue for 2.5 mg ascal/rivarox twice per day and 20 mg rosuvastatin per day.On (b)(6) 2023, 1568 days post index procedure, the subject was hospitalized for planned treatment and evaluation.On the basis of symptoms and diagnostics finding, the subject was diagnosed with fontaine stage 3 paod (peripheral arterial occlusive disease) due to gangrene and stenosis of femoral- artery on the left.The pre-marked great saphenous vein (gsv) was released and removed with multiple incisions.Tunnel was made with the tunneler device behind the condylar block along with the sartorius.Then, groin was clamped and arteriotomy was done followed by thromboendarterectomy (tea).Suturing was reversed of gsv with prolene 6.0.Tunneling was done under 2 phases; pressure followed by clamps on the popliteal artery and arteriotomy was performed with custom bypass.Back flow from the lower leg reasonable was noticed finally and stitching of bypass prolene 6.0 was done.During procedure, the subject had 300 ml blood loss; however, no blood transfusion was required.Postoperative treatment showed good pulsations across the bypass and all wounds were closed in layers.On (b)(6) 2023, the subject was discharged home in good condition and was recommended to start fraxiparine and continued ascal, clopidogrel, and 2.5 mg rivaroxaban twice a day.On the same day, the subject was readmitted for observation after bleeding and for digit v wound checkup on the left.Physical examination showed left leg supple, and calf had some edema, left foot was warm with good sensory motor skills and digit v necrotic wound was not moist on the left.On (b)(6) 2023, the subject was discharged and was advised to restart diuretics and rinse toe once per day and apply dry dressing.It was further reported that on (b)(6) 2023, although the subject was recommended for discharge, bleeding was noted for which the subject was readmitted for observation and digit v wound checkup on the left.The previously reported administration of fraxiparine and ascal, clopidogrel, and 2.5 mg rivaroxaban twice a day was not started until (b)(6) 2023.

Event Description

Eminent 1929-emi-017.It was reported that stent occlusion occurred, and the patient underwent interventional procedure to treat the event.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in left mid superficial femoral artery (sfa) with 100% stenosis.The lesion was 60 mm long with a proximal reference vessel diameter of 4 mm, a distal reference vessel diameter of 4 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 stents.Following post dilation, the residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet medications.On (b)(6) 2023, 1535 days post index procedure, the subject was diagnosed with fontaine stage 4 pavd (peripheral arterial vascular disease) due to the stent occlusion of left sfa.The subject was recommended for 2.5 mg ascal/rivarox twice per day.On (b)(6) 2023, duplex imaging showed severe plaque formation origin left sfa and stenosis 75-99%, psv ratio 10.1 and calcified trajectory, followed by occlusion.Also, occlusion of stent left sfa up to distal and substantial plaque formation in left popliteal artery and especially distal very narrow patent lumen popliteal artery.On (b)(6) 2023, the subject revisited due to pain at rest and night.Physical examination showed digit v defect of left foot.The subject was advised to continue for 2.5 mg ascal/rivarox twice per day and 20 mg rosuvastatin per day.On (b)(6) 2023, 1568 days post index procedure, the subject was hospitalized for planned treatment and evaluation.On the basis of symptoms and diagnostics finding, the subject was diagnosed with fontaine stage 3 paod (peripheral arterial occlusive disease) due to gangrene and stenosis of femoral- artery on the left.The pre-marked great saphenous vein (gsv) was released and removed with multiple incisions.Tunnel was made with the tunneler device behind the condylar block along with the sartorius.Then, groin was clamped and arteriotomy was done followed by thromboendarterectomy (tea).Suturing was reversed of gsv with prolene 6.0.Tunneling was done under 2 phases; pressure followed by clamps on the popliteal artery and arteriotomy was performed with custom bypass.Back flow from the lower leg reasonable was noticed finally and stitching of bypass prolene 6.0 was done.During procedure, the subject had 300 ml blood loss; however, no blood transfusion was required.Postoperative treatment showed good pulsations across the bypass and all wounds were closed in layers.On (b)(6) 2023, the subject was discharged home in good condition and was recommended to start fraxiparine and continued ascal, clopidogrel, and 2.5 mg rivaroxaban twice a day.On the same day, the subject was readmitted for observation after bleeding and for digit v wound checkup on the left.Physical examination showed left leg supple, and calf had some edema, left foot was warm with good sensory motor skills and digit v necrotic wound was not moist on the left.On (b)(6) 2023, the subject was discharged and was advised to restart diuretics and rinse toe once per day and apply dry dressing.It was further reported that on (b)(6) 2023, although the subject was recommended for discharge, bleeding was noted for which the subject was readmitted for observation and digit v wound checkup on the left.The previously reported administration of fraxiparine and ascal, clopidogrel, and 2.5 mg rivaroxaban twice a day was not started until (b)(6) 2023.It was further reported that on 28-aug-2023, the event was considered to be resolved.

Manufacturer Narrative

A1 - patient identifier: study id (b)(6).A2 - age at time of event: the subject was 65 years old at the time of study enrollment.Updated field: b5 - describe event or problem.

Event Description

Eminent (b)(4).It was reported that stent occlusion occurred, and the patient underwent interventional procedure to treat the event.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in left mid superficial femoral artery (sfa) with 100% stenosis.The lesion was 60 mm long with a proximal reference vessel diameter of 4 mm, a distal reference vessel diameter of 4 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 stents.Following post dilation, the residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet medications.On (b)(6) 2023, 1535 days post index procedure, the subject was diagnosed with fontaine stage 4 pavd (peripheral arterial vascular disease) due to the stent occlusion of left sfa.The subject was recommended for 2.5 mg ascal/rivarox twice per day.On (b)(6) 2023, duplex imaging showed severe plaque formation origin left sfa and stenosis 75-99%, psv ratio 10.1 and calcified trajectory, followed by occlusion.Also, occlusion of stent left sfa up to distal and substantial plaque formation in left popliteal artery and especially distal very narrow patent lumen popliteal artery.On (b)(6) 2023, the subject revisited due to pain at rest and night.Physical examination showed digit v defect of left foot.The subject was advised to continue for 2.5 mg ascal/rivarox twice per day and 20 mg rosuvastatin per day.On (b)(6) 2023, 1568 days post index procedure, the subject was hospitalized for planned treatment and evaluation.On the basis of symptoms and diagnostics finding, the subject was diagnosed with fontaine stage 3 paod (peripheral arterial occlusive disease) due to gangrene and stenosis of femoral- artery on the left.The pre-marked great saphenous vein (gsv) was released and removed with multiple incisions.Tunnel was made with the tunneler device behind the condylar block along with the sartorius.Then, groin was clamped and arteriotomy was done followed by thromboendarterectomy (tea).Suturing was reversed of gsv with prolene 6.0.Tunneling was done under 2 phases; pressure followed by clamps on the popliteal artery and arteriotomy was performed with custom bypass.Back flow from the lower leg reasonable was noticed finally and stitching of bypass prolene 6.0 was done.During procedure, the subject had 300 ml blood loss; however, no blood transfusion was required.Postoperative treatment showed good pulsations across the bypass and all wounds were closed in layers.On (b)(6) 2023, the subject was discharged home in good condition and was recommended to start fraxiparine and continued ascal, clopidogrel, and 2.5 mg rivaroxaban twice a day.On the same day, the subject was readmitted for observation after bleeding and for digit v wound checkup on the left.Physical examination showed left leg supple, and calf had some edema, left foot was warm with good sensory motor skills and digit v necrotic wound was not moist on the left.On (b)(6) 2023, the subject was discharged and was advised to restart diuretics and rinse toe once per day and apply dry dressing.It was further reported that on (b)(6) 2023, although the subject was recommended for discharge, bleeding was noted for which the subject was readmitted for observation and digit v wound checkup on the left.The previously reported administration of fraxiparine and ascal, clopidogrel, and 2.5 mg rivaroxaban twice a day was not started until (b)(6) 2023.It was further reported that on (b)(6) 2023, the event was considered to be resolved.It was further reported that on (b)(6) 2023, that target lesion was 100% stenosed and located in the right proximal, middle, to distal sfa, involving proximal popliteal artery.The target lesion had a 120 mm lesion length, and a reference vessel diameter of 4 mm.In addition to the previously reported postoperative treatment observations, there was 0% stenosis and no thrombus seen.

Manufacturer Narrative

A1 - patient identifier: study id (b)(6).A2 - age at time of event: the subject was 65 years old at the time of study enrollment.

• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17673859
• MDR Text Key: 322609669
• Report Number: 2124215-2023-47482
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022415212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White