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); Obstruction/Occlusion (2422); Pseudoaneurysm (2605); Thrombosis/Thrombus (4440)

Event Date 01/16/2023

Event Type  Injury  

Manufacturer Narrative

A1 - patient identifier (b)(6).A2 - age at time of event: the patient was 68 years old at the time of study enrollment.

Event Description

(b)(4) eminent clinical study.It was reported that stent thrombosis and revascularization of the left study stent occurred 1496 days post-index procedure.The subject was enrolled in the eminent study on 12-dec-2018 and the index procedure was performed on the same day.The target lesion was located in the left-mid superficial femoral artery (sfa) with 100% stenosis and was 130 mm long with a proximal reference vessel diameter of 4.49 mm and distal reference vessel diameter of 4.49 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of two 6 mm x 100 mm study stents.Following post dilation, the residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medications.On (b)(6) 2023, 1496 days post index procedure, the subject presented with an unknown symptom.Ultrasound detected an occlusion in the area of the implanted stent, consistent with peripheral arterial occlusive disease (paod) iib in the left sfa.On (b)(6) 2023, 1552 days post index procedure, the subject was hospitalized for planned treatment and evaluation.On the same day, digital subtraction angiography (dsa) of the upper left leg revealed a long-segment in the real lumen with distal occlusion of the sfa.The occluded segment spanned over the entire course of the implanted stent, up to the femoral popliteal junction.Thrombolysis was started with a total of 2 mg of alteplase of local intra-artery fibrinolysis, with initial alteplase infiltration of the entire occlusion.Following thrombolysis, angiography revealed free perfusion of the two stents with an aneurysmal change measuring up to 1.2 cm in diameter around the first proximal stent in the sfa, as well as incipient dilations around the second distal stent.No change was noticed in the 3-vessel runoff at the lower leg and foot arteries when compared with a dsa from the previous day.On (b)(6) 2023, 1553 days post index procedure, 100% stenosis with thrombus in the left proximal-to-distal sfa involving the peripheral pulmonary artery (ppa) with 174 mm lesion length was treated.A guide wire was passed through the two stents in the sfa and in the popliteal artery, and a 5 mm x 250 mm self-expanding non-bsc stent was implanted over the proximal and distal stents in the sfa.Following stent placement, the stents were dilated using a 4 mm balloon.Post procedure, angiomorphology showed the proximal end of the new stent graft was 4 cm above and the distal end was 2 cm below the existing stents.The new stent graft expanded well and was freely perfused, and the aneurysmal change was completely excluded.Stent placement resulted in 0% of residual stenosis and no thrombus was seen.The event was considered to be recovered/resolved on the same day.On (b)(6) 2023, pseudoaneurysm on the left could not be imaged via ultrasound.On (b)(6) 2023, the subject was discharged from the hospital on recommendation to take 300 mg plavix tomorrow as a loading dose, and then 75 mg 1x1 for 6 weeks.No further patient complications were reported.

Event Description

S2366 eminent clinical study.It was reported that stent thrombosis and revascularization of the left study stent occurred 1496 days post-index procedure.The subject was enrolled in the eminent study on 12-dec-2018 and the index procedure was performed on the same day.The target lesion was located in the left-mid superficial femoral artery (sfa) with 100% stenosis and was 130 mm long with a proximal reference vessel diameter of 4.49 mm and distal reference vessel diameter of 4.49 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of two 6 mm x 100 mm study stents.Following post dilation, the residual stenosis was 0%.On (b)(6) 2018 the subject was discharged with antiplatelet medications.On (b)(6) 2023 1496 days post index procedure, the subject presented with an unknown symptom.Ultrasound detected an occlusion in the area of the implanted stent, consistent with peripheral arterial occlusive disease (paod) iib in the left sfa.On (b)(6) 2023 1552 days post index procedure, the subject was hospitalized for planned treatment and evaluation.On the same day, digital subtraction angiography (dsa) of the upper left leg revealed a long-segment in the real lumen with distal occlusion of the sfa.The occluded segment spanned over the entire course of the implanted stent, up to the femoral popliteal junction.Thrombolysis was started with a total of 2 mg of alteplase of local intra-artery fibrinolysis, with initial alteplase infiltration of the entire occlusion.Following thrombolysis, angiography revealed free perfusion of the two stents with an aneurysmal change measuring up to 1.2 cm in diameter around the first proximal stent in the sfa, as well as incipient dilations around the second distal stent.No change was noticed in the 3-vessel runoff at the lower leg and foot arteries when compared with a dsa from the previous day.On (b)(6) 2023 1553 days post index procedure, 100% stenosis with thrombus in the left proximal-to-distal sfa involving the peripheral pulmonary artery (ppa) with 174 mm lesion length was treated.A guide wire was passed through the two stents in the sfa and in the popliteal artery, and a 5 mm x 250 mm self-expanding non-bsc stent was implanted over the proximal and distal stents in the sfa.Following stent placement, the stents were dilated using a 4 mm balloon.Post procedure, angiomorphology showed the proximal end of the new stent graft was 4 cm above and the distal end was 2 cm below the existing stents.The new stent graft expanded well and was freely perfused, and the aneurysmal change was completely excluded.Stent placement resulted in 0% of residual stenosis and no thrombus was seen.The event was considered to be recovered/resolved on the same day.On (b)(6) 2023 pseudoaneurysm on the left could not be imaged via ultrasound.On (b)(6) 2023 the subject was discharged from the hospital on recommendation to take 300 mg plavix tomorrow as a loading dose, and then 75 mg 1x1 for 6 weeks.No further patient complications were reported.It was further reported that the previously unknown symptom reported on (b)(6) 2023 was related to the subject's walking ability.The subject reported that he could normally walk about 10 km in one hour.However, at the time, it was taking him an hour and a half to walk three km.In addition to the previously reported diagnosis of paod, the subject was also diagnosed with a circulatory disorder on the left sfa on (b)(6) 2023.Additionally, it was previously reported that an aneurysmal change was detected on (b)(6) 2023.Further information received revealed that on 14-mar-2023, the subject developed an aneurysm around the implanted stent.According to the study site, the aneurysm led to a prolonged hospitalization.

Manufacturer Narrative

A1 - patient identifier - (b)(6).A2 - age at time of event: the patient was 68 years old at the time of study enrollment.Updated fields: b5, b6, b7 d3 - manufacturer address 1, manufacturer city, manufacturer state, manufacturer zip/postal code h6 - patient codes updated from e0513 to e0501 based on revised information received.

• 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: 16723673
• MDR Text Key: 313117452
• Report Number: 2124215-2023-16660
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021742143
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2018
• 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