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 Obstruction/Occlusion (2422)

Event Date 01/12/2022

Event Type  Injury  

Event Description

Study name: (b)(6).It was reported re-occlusion occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2019 and the index procedure was performed on the same day.The 100% stenosis target lesion was located in the right distal superficial femoral artery (sfa) involving the proximal popliteal artery (ppa).And was 140 mm long with a proximal reference vessel diameter of 5 mm and distal reference vessel diameter of 5 mm classified as transatlantic intersociety consensus (tasc) ii b lesion.The target lesion was treated with pre-dilatation followed by placement of two study stents, a 6 mm x 120 mm and a 6 mm x 60 mm.Following post-dilation, residual stenosis was 0%, and the subject was discharged with antiplatelet therapy the next day.(b)(6) 2022, 896 days post-index procedure, the subject was diagnosed with in-stent re-occlusion of the sfa in the right leg.The subject has been scheduled for revascularization on (b)(6) 2022.(b)(6) 2022, 904 days post-index procedure, the subject was presented to the clinic with complaints about claudication symptoms which have existed for approx.14 days and have been constant in their intensity after walking a distance of less than 200 "mts" and the occasional feeling of coldness in the right toes.Pre-interventional angiography performed revealed, common iliac artery and external iliac artery with diffuse wall change without relevant stenosis.Superficial femoral artery with long-distance stenting and long-distance occlusion from the origin after a short stub.Long-distance stenting and occlusion in the popliteal artery.Reperfusion was noted at the level of the tibial-fibular trunk with patency of the anterior tibial artery and the posterior tibial artery.The 100% stenosis from the right proximal to distal sfa with a reference vessel diameter of 6 mm was treated by performing thrombectomy in the tibial-femoral trunk.Later, angioplasty was performed using two non bsc balloons (5/80 mm and 6/300 mm) to remove the segmental residual thrombotic deposits that were noted during the angiography check.A final angioplasty was performed using a non bsc drug-coated balloon (4/40 mm) in the distal p3 segment to treat the relevant stenosis.Post-procedure, revealed 10% final residual restenosis, no thrombus, and no indication of any peripheral embolization.(b)(6) 2022, arterial doppler occlusion pressures performed, revealed ankle-brachial index (abi) at rest (right/left) was 0.8/0.7.Electronic segmental oscillography at right performed showed thigh and calf slightly pathological and ankle was normal.Light reflection plethysmography of the toes on both sides revealed a normal oscillogram of toes (with a tendency to overshoot) on the right.Color duplex sonography performed on the right side revealed superficial femoral artery and popliteal artery free, hypoechoic (border) around the stent over the entire length.(b)(6) 2022, the subject was discharged.

Manufacturer Narrative

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

• 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: 13501743
• MDR Text Key: 286750596
• Report Number: 2134265-2022-00596
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• 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
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023541897
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2022
• Initial Date FDA Received: 02/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2019
• 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