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 Inflammation (1932); Thrombosis/Thrombus (4440)

Event Date 07/06/2020

Event Type  Injury  

Event Description

Eminent clinical study.It was reported there was in-stent reocclusion.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 distal sfa with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 4.7 mm and distal reference vessel diameter of 5.3 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation followed by placement of a 7 mm x 100 mm study stent.Post treatment, dissection was noted, hence an additional study stent 6 mm x 80 mm was placed.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2023, 1238 days post index procedure, the subject visited to the clinic with unknown symptoms and on the same day, the sonography examination revealed suggestive of a thrombo-occlusive event in the superficial femoral artery (sfa), which was approximately in the same area as the proximal end of the occlusion (sonographically 10 cm before the end of the stent) treated by lysis in 2020.On (b)(6) 2023, the subject was hospitalized with a recurrent occlusion of the stent in the left sfa.On the same day the subject was admitted for further evaluation and treatment.Angiography revealed 25-cm-long vascular occlusion from the middle sfa up to the distal stent end at the left femoropopliteal junction.Additionally, imaging of non-occluding thrombi in the p1 segment and at the trifurcation in the lower leg was noted.Also, there is a poorly contrasted triple-vessel outflow in the lower leg and the foot arteries are also poorly contrasted.Upon consultation, the subject was recommended to undergo interventional procedure as a treatment for this event.On (b)(6) 2023, 1286 days post index procedure, subject was treated by performing lysis therapy across a 25-cm-long in-stent vascular occlusion from the middle sfa to the distal end of the stent at the left femoropopliteal junction by bolus administration of 4mg actilyse through the occlusion.On (b)(6) 2023, angiography performed revealed diffuse aneurysmal change of up to 11 mm in diameter around the existing stents.In the lower leg, there is an unobstructed triple-vessel outflow with tiny contrast medium recesses in the region of the trifurcation, suspected of being tiny, non-flow-limiting wall-adherent thrombi.The foot arteries are freely perfused.To treat the same, on (b)(6) 2023, 100% stenosis in the distal sfa (target lesion) was treated by implanting a 6 mm x 250 mm non-boston scientific self-expandable stent and subsequent dilatation by using a 5 mm balloon.Post procedure, the stent graft is well unfolded and freely perfused, the diffuse aneurysmal change around the existing stents is completely excluded from the arterial perfusion.Good outflow in the lower leg and the procedure was uncomplicated.On (b)(6) 2023, the event was considered resolved recovered.On (b)(6) 2023, the subject was discharged and recommended to take aspirin as a permanent therapy and bed rest for six hours.It was further reported that the study stents were implanted subintimal and they are overlapping.

Manufacturer Narrative

E1: initial reporter address 1: (b)(6).

Manufacturer Narrative

(b)(6).

Event Description

Eminent clinical study.It was reported there was in-stent reocclusion.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 distal sfa with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 4.7 mm and distal reference vessel diameter of 5.3 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation followed by placement of a 7 mm x 100 mm study stent.Post treatment, dissection was noted, hence an additional study stent 6 mm x 80 mm was placed.Following post dilation, residual stenosis was 0%.On (b)(6) 2019 the subject was discharged with antiplatelet therapy.On (b)(6) 2023 1238 days post index procedure, the subject visited to the clinic with unknown symptoms and on the same day, the sonography examination revealed suggestive of a thrombo-occlusive event in the superficial femoral artery (sfa), which was approximately in the same area as the proximal end of the occlusion (sonographically 10 cm before the end of the stent) treated by lysis in 2020.On (b)(6) 2023 the subject was hospitalized with a recurrent occlusion of the stent in the left sfa.On the same day the subject was admitted for further evaluation and treatment.Angiography revealed 25-cm-long vascular occlusion from the middle sfa up to the distal stent end at the left femoropopliteal junction.Additionally, imaging of non-occluding thrombi in the p1 segment and at the trifurcation in the lower leg was noted.Also, there is a poorly contrasted triple-vessel outflow in the lower leg and the foot arteries are also poorly contrasted.Upon consultation, the subject was recommended to undergo interventional procedure as a treatment for this event.On (b)(6) 2023 1286 days post index procedure, subject was treated by performing lysis therapy across a 25-cm-long in-stent vascular occlusion from the middle sfa to the distal end of the stent at the left femoropopliteal junction by bolus administration of 4mg actilyse through the occlusion.On (b)(6) 2023 angiography performed revealed diffuse aneurysmal change of up to 11 mm in diameter around the existing stents.In the lower leg, there is an unobstructed triple-vessel outflow with tiny contrast medium recesses in the region of the trifurcation, suspected of being tiny, non-flow-limiting wall-adherent thrombi.The foot arteries are freely perfused.To treat the same, on (b)(6) 2023 100% stenosis in the distal sfa (target lesion) was treated by implanting a 6 mm x 250 mm non-boston scientific self-expandable stent and subsequent dilatation by using a 5 mm balloon.Post procedure, the stent graft is well unfolded and freely perfused, the diffuse aneurysmal change around the existing stents is completely excluded from the arterial perfusion.Good outflow in the lower leg and the procedure was uncomplicated.On (b)(6) 2023 the event was considered resolved/ recovered.On (b)(6) 2023 the subject was discharged and recommended to take aspirin as a permanent therapy and bed rest for six hours.It was further reported on (b)(6) 2023 good outflow in the lower leg and the procedure was uncomplicated with 0% residual stenosis noted and no thrombus was seen.On (b)(6) 2023 the subject was discharged with good general condition and relative well-being after ruling out a pseudoaneurysm.

• 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: 16737401
• MDR Text Key: 313291464
• Report Number: 2124215-2023-16775
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023510328
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Race: White