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 Problem Thrombosis/Thrombus (4440)

Event Date 08/08/2021

Event Type  Injury  

Event Description

(b)(6) study.It was reported that stent thrombosis occurred.The subject was enrolled in the study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery with 100% stenosis and was 79 mm long with a proximal reference vessel diameter of 4.76 mm and distal reference vessel diameter of 4.82 mm and was classified as a tasc ii b lesion.Target lesion was treated with pre-dilatation, followed by 6 mm x 100 mm eluvia drug-eluting vascular stent system was used for treating the target lesion.Post dilatation was performed with final residual stenosis of 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2021, 893 days post-index procedure, the subject presented with unknown symptoms and was diagnosed with occlusion in the stent.The subject was recommended to undergo a revascularization procedure for this event.On (b)(6) 2021,the subject was hospitalized for further treatment and evaluation.The subject underwent thrombolysis as a treatment for this event.On (b)(6) 2021, the event was considered resolved and on (b)(6) 2021, the subject was discharged.

Manufacturer Narrative

Age at time of event: (b)(6) years old at time of enrollment.

Manufacturer Narrative

A2 - age at time of event: 61 years old at time of enrollment.

Event Description

Eminent study.It was reported that stent thrombosis occurred.The subject was enrolled in the study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery with 100% stenosis and was 79 mm long with a proximal reference vessel diameter of 4.76 mm and distal reference vessel diameter of 4.82 mm and was classified as a tasc ii b lesion.Target lesion was treated with pre-dilatation, followed by 6 mm x 100 mm eluvia drug-eluting vascular stent system was used for treating the target lesion.Post dilatation was performed with final residual stenosis of 0%.On (b)(6), 2019, the subject was discharged with antiplatelet therapy.On (b)(6), 2021, 893 days post-index procedure, the subject presented with unknown symptoms and was diagnosed with occlusion in the stent.The subject was recommended to undergo a revascularization procedure for this event.On (b)(6), 2021,the subject was hospitalized for further treatment and evaluation.The subject underwent thrombolysis as a treatment for this event.On (b)(6) 2021, the event was considered resolved and on (b)(6), 2021, the subject was discharged.It was further reported that the target lesion was located in the right distal superficial femoral artery.On (b)(6) 2021, additional angiography core lab in right proximal to distal sfa revealed patent inflow and outflow.Isr stenosis pattern was occlusive with presence of thrombus and absence of aneurysm.On (b)(6) 2021, 915 days post index procedure, intra-arterial loco-regional lysis therapy was initiated in the target lesion and suggested to continue for 24 hours.On (b)(6) 2021, lysis follow-up showed a complete reopening of perfusion.Post treatment, angiography findings revealed 'complete reopening of the occluded vessel segments in the superficial femoral artery.Only showed minor atherosclerotic contour irregularities in the stented section of the distal superficial femoral artery.The stent appears to be well unfolded.Over time, regular perfusion is recovered in the popliteal artery with triple-vessel outflow in the lower leg.A small occlusion can be seen, which is most likely embolic, in the proximal area of the plantar artery; however, this may not be clinically relevant'.The duplex ultrasound follow-up was normal and pseudo-aneurysm could be excluded.On (b)(6) 2021, the event was considered recovered/ resolved.On (b)(6) 2021, the subject was discharged in a good general condition with recommendation to continue thrombo ass 100 mg for long-term antiplatelet treatment.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13972477
• MDR Text Key: 288358652
• Report Number: 2134265-2022-03444
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• PMA/PMN Number: P180011
• 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: 06/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/19/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021863988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male
• Patient Race: White