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 Ischemia (1942); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 05/05/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(4) eminent.It was reported that the subject experienced stent thrombosis and occlusion 1529 days post index procedure.On (b)(6) 2019, the subject was enrolled in the clinical study and the index procedure was performed on the same day.The target lesion was located in the left mid superficial femoral artery (sfa).The target lesion was reportedly 100% stenosed, and was 60 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm.The lesion was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by placement of an eluvia eu, 6x120, 75 cm.Following post dilation, residual stenosis was reportedly 0%.The subject was discharged with antiplatelet therapy the same day.On (b)(6) 2023, 1529 days post index procedure, the subject presented with unknown symptoms.The subject was diagnosed with occlusion of the study stent in the left sfa.On (b)(6) 2023, the subject was hospitalized and underwent interventional procedure to treat the event.Target lesion (001) located in the left mid to distal sfa involving the proximal popliteal artery (ppa).The lesion was 100% stenosed with lesion length of 300 mm and reference vessel diameter of 0 mm.Target lesion (001) was treated with thrombolysis.Post procedure, there was 95% residual stenosis and thrombus was seen.Target lesion (002) was 90% stenosed with lesion length of 230 mm and reference vessel diameter of 2 mm.Target lesion was treated by percutaneous angioplasty (pta) followed by thrombolysis.Post procedure, there was 30% residual stenosis and thrombus was seen.Target lesion (003) was 30% stenosed with lesion length of 300 mm and reference vessel diameter of 4 mm.Target lesion was treated with thrombolysis.Post procedure, there was 30% residual stenosis and thrombus was seen.The event was also treated medically.On (b)(6) 2023, the subject was discharged.

Manufacturer Narrative

A1: patient identifier: (b)(6).A1: age at time of event: the subject was 65 years old at the time of study enrollment.Updated fields: b5: describe event or problem.G1: mfr contact first name, mfr contact last name, mfr contact phone number, mfr contact email.H6: patient codes, impact codes, evaluation method codes, evaluation result codes, evaluation result codes.

Event Description

(b)(4) eminent.It was reported that the subject experienced stent thrombosis and occlusion 1529 days post index procedure.On (b)(6) 2019, the subject was enrolled in the clinical study and the index procedure was performed on the same day.The target lesion was located in the left mid superficial femoral artery (sfa).The target lesion was reportedly 100% stenosed, and was 60 mm long with a proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm.The lesion was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by placement of an eluvia eu, 6x120, 75 cm.Following post dilation, residual stenosis was reportedly 0%.The subject was discharged with antiplatelet therapy the same day.On (b)(6) 2023, 1529 days post index procedure, the subject presented with unknown symptoms.The subject was diagnosed with occlusion of the study stent in the left sfa.On (b)(6) 2023, the subject was hospitalized and underwent interventional procedure to treat the event.Target lesion (001) located in the left mid to distal sfa involving the proximal popliteal artery (ppa).The lesion was 100% stenosed with lesion length of 300 mm and reference vessel diameter of 0 mm.Target lesion (001) was treated with thrombolysis.Post procedure, there was 95% residual stenosis and thrombus was seen.Target lesion (002) was 90% stenosed with lesion length of 230 mm and reference vessel diameter of 2 mm.Target lesion was treated by percutaneous angioplasty (pta) followed by thrombolysis.Post procedure, there was 30% residual stenosis and thrombus was seen.Target lesion (003) was 30% stenosed with lesion length of 300 mm and reference vessel diameter of 4 mm.Target lesion was treated with thrombolysis.Post procedure, there was 30% residual stenosis and thrombus was seen.The event was also treated medically.On (b)(6) 2023, the subject was discharged.No further patient complications were reported.It was further reported that the unknown symptoms the subject experienced on (b)(6) 2023 included pain in the left lower calf that started after walking approximately 1-2, which improved when the leg was raised.On (b)(6) 2023, the subject noted leg was white and cold on the left with no paint at rest.On (b)(6) 2023, the subject was admitted to the intensive care unit for further treatment and evaluation.Physical examination showed cool and white foot from 10 cm above the ankle.Doppler showed no signal; however, popliteal artery was monophasic on the left.Motor skills was fully intact and both plantar and dorsum foot intact.Ct scan intravenous contrast revealed occlusion of left sfa with occlusion of the stent in-situ.More distally with no clear staining of the popliteal artery and calcification of popliteal artery with no staining of crural vessels on the left.The subject was diagnosed with acute limb ischemia on the left due to occlusion of stent in sfa.In addition to the previously reported thrombolysis performed on (b)(6) 2023, the subject was also treated with alteplase.Post procedure, second control check angiography showed patency of the sfa resulted in 95% residual stenosis and thrombus was seen; however, thrombolysis could be stopped.On (b)(6) 2023, the subject was again admitted to the surgery ward due to stent occlusion on the left.Although previously reported that treatment of target lesions (002) and (003) occurred on (b)(6) 2023, it actually occurred on (b)(6) 2023.In addition to the previously reported pta and thrombolysis, target lesion (002) was treated with 5,000 u heparin intra-arterial and 5 mg rtpa intra-arterial.Post procedure, control check angiography showed a gracile but patent sfa and popliteal artery.In the lower leg, three crural vessels outflow mainly via the posterior tibial artery towards the foot.The foot was still cool just like the other foot with no pain and good motor skills.After 24 hours, alteplase thrombolysis was discontinued and rtpa was also stopped, and heparin was given over the infusion.Ultrasound showed good pulsations and no clear block in the vessel post some leakage.Hence, the groin was access and closed with angio-seal.On (b)(6) 2023, control check was performed on thrombolysis and improved clinical images were seen.However, residual thrombus in distal sfa was still noticed along with high-grade stenosis just distal to the stent and multiple stenosis in the distal sfa and supragenual popliteal artery.Percutaneous transluminal angioplasty was performed to the entire section with an unknown 4 mm x 20 mm balloon, and to the proximal section with an unknown 5 mm x 80 mm balloon.There was a good outcome with scattered residual walled and residual thrombus; hence, new thrombolysis catheter was placed and continued.The imaging was uncomplicated, and the bladder catheter could be removed.As previously reported, the subject was discharged, but against medical advice, as the subject did not want to wait.On (b)(6) 2023, 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.No further patient complications were reported.

• 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: 17144959
• MDR Text Key: 317451183
• Report Number: 2124215-2023-30912
• 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
• Report Date: 07/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• 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: 06/13/2023
• 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