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 (2100)

Event Date 05/25/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier (b)(6).Subject was a (b)(6) at time of enrollment.

Event Description

(b)(6).It was reported that thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right ostial to mid superficial femoral artery (sfa) with 100% stenosis and was 180 mm long with a proximal reference vessel diameter of 5.7 mm and distal reference vessel diameter of 4.1 mm and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation with 3 balloons, followed by direct placement of two 6 mm x 120 mm eluvia stent and two 5 mm x 100 mm non-bsc stents.Following post dilation, residual stenosis was 25%.On (b)(6) 2020, the subject noted with thrombus in the sfa.On (b)(6) 2020, the subject was hospitalized for further evaluation and treatment.A non-bsc catheter was placed proximal in the stent in the sfa and thrombolysis was performed to treat the right sfa.On (b)(6) 2020, follow-up angiography showed wall irregularities in distal superficial femoral artery, no other abnormalities were noted, post which a decision was made to opt for dilatation of the distal stenosis in the stent using a 5 mm balloon angioplasty.Post procedure, good results were noted on angiography.On (b)(6) 2020, angiography revealed slightly irregular contour within the stents in the right superficial femoral artery with the stenosis distal in the stent.To treat this, dilatation was performed using a 4 mm x 80 mm balloon.On the same day, the event was considered to be recovered/resolved.On (b)(6) 2020, subject was discharged on antiplatelet medication.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: subject was a 72-year-old at time of enrollment.

Event Description

Eminent clinical trial.It was reported that thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right ostial to mid superficial femoral artery (sfa) with 100% stenosis and was 180 mm long with a proximal reference vessel diameter of 5.7 mm and distal reference vessel diameter of 4.1 mm and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation with 3 balloons, followed by direct placement of two 6 mm x 120 mm eluvia stent and two 5 mm x 100 mm non-bsc stents.Following post dilation, residual stenosis was 25%.On (b)(6) 2020, the subject noted with thrombus in the sfa.On (b)(6) 2020, the subject was hospitalized for further evaluation and treatment.A non-bsc catheter was placed proximal in the stent in the sfa and thrombolysis was performed to treat the right sfa.On (b)(6) 2020, follow-up angiography showed wall irregularities in distal superficial femoral artery, no other abnormalities were noted, post which a decision was made to opt for dilatation of the distal stenosis in the stent using a 5 mm balloon angioplasty.Post procedure, good results were noted on angiography.On (b)(6) 2020, angiography revealed slightly irregular contour within the stents in the right superficial femoral artery with the stenosis distal in the stent.To treat this, dilatation was performed using a 4 mm x 80 mm balloon.On the same day, the event was considered to be recovered / resolved.On (b)(6) 2020, subject was discharged on antiplatelet medication.It was further reported that during the index procedure post treatment, subject was noted to have dissection in the occluded vessel for which two additional non-bsc stents were implanted.The thrombus was discovered in the subject on (b)(6) 2020.Angiography at right leg revealed complete occlusion in the stent of right superficial femoral artery.Also, suspicion in-stent stenosis in the distal segment of the superficial femoral artery.

Manufacturer Narrative

A1: patient identifier (b)(6).A2: subject was a 72-year-old at time of enrollment.

Event Description

Eminent clinical trial.It was reported that thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.The target lesion was located in right ostial to mid superficial femoral artery (sfa) with 100% stenosis and was 180 mm long with a proximal reference vessel diameter of 5.7 mm and distal reference vessel diameter of 4.1 mm and was classified as tasc ii c lesion.The target lesion was treated with pre-dilatation with 3 balloons, followed by direct placement of two 6 mm x 120 mm eluvia stent and two 5 mm x 100 mm non-bsc stents.Following post dilation, residual stenosis was 25%.On (b)(6) 2020, the subject noted with thrombus in the sfa.On (b)(6) 2020, the subject was hospitalized for further evaluation and treatment.A non-bsc catheter was placed proximal in the stent in the sfa and thrombolysis was performed to treat the right sfa.On 26 may 2020, follow-up angiography showed wall irregularities in distal superficial femoral artery, no other abnormalities were noted, post which a decision was made to opt for dilatation of the distal stenosis in the stent using a 5 mm balloon angioplasty.Post procedure, good results were noted on angiography.On (b)(6) 2020, angiography revealed slightly irregular contour within the stents in the right superficial femoral artery with the stenosis distal in the stent.To treat this, dilatation was performed using a 4 mm x 80 mm balloon.On the same day, the event was considered to be recovered/resolved.On (b)(6) 2020, subject was discharged on antiplatelet medication.It was further reported that during the index procedure post treatment, subject was noted to have dissection in the occluded vessel for which two additional non-bsc stents were implanted.The thrombus was discovered in the subject on (b)(6) 2020.Angiography at right leg revealed complete occlusion in the stent of right superficial femoral artery.Also, suspicion in-stent stenosis in the distal segment of the superficial femoral artery.It was further reported that on (b)(6) 2020, alteplase bolus was administered.The target lesion was right proximal to the distal sfa involving the proximal popliteal artery (ppa) with 0% stenosis and was 300 mm long with a reference vessel diameter of 5 mm.On 27 may 2020, post-procedure revealed 75% residual stenosis.

• 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
• MDR Report Key: 10139535
• MDR Text Key: 194681152
• Report Number: 2134265-2020-07752
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022326837
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Patient Sequence Number: 1
• Treatment: ELUVIA 6X120X130; ELUVIA 6X120X130; ELUVIA 6X120X130; ELUVIA 6X120X130
• Patient Outcome(s): Required Intervention