MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24620

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Reocclusion (1985)

Event Date 11/03/2020

Event Type  Injury  

Event Description

(b)(6) clinical study.It was reported that in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was in the right distal superficial femoral artery (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 6 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with pre-dilatation and a placement of a 6 mm x 100 mm study stent.Following post-dilatation, residual stenosis was 0%.Subsequently, a 6 mm x 100 mm stent was opened but not inserted.On (b)(6) 2016 the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020 1575 days post index procedure, the subject was noted to have in-stent stenosis.Subsequently subject was hospitalized for further evaluation and treatment.100% in-stent stenosis was noted in the right sfa.It was treated by percutaneous transluminal angioplasty (pta) stenting with 2 stents and dilation with drug coated balloon.Following post dilation, the residual stenosis was 10%.On (b)(6) 2020, the event was considered to be resolved with residual effects and the subject was discharged on the same day.

Event Description

Imperial clinical study.It was reported that in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was in the right distal superficial femoral artery (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 6 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with pre-dilatation and a placement of a 6 mm x 100 mm study stent.Following post-dilatation, residual stenosis was 0%.Subsequently, a 6 mm x 100 mm stent was opened but not inserted.On (b)(6) 2016 the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020 1575 days post index procedure, the subject was noted to have in-stent stenosis.Subsequently subject was hospitalized for further evaluation and treatment.100% in-stent stenosis was noted in the right sfa.It was treated by percutaneous transluminal angioplasty (pta) (stenting with 2 stents, dilation with drug coated balloon.Following post dilation, the residual stenosis was 10%.On (b)(6) 2020, the event was considered to be resolved with residual effects and the subject was discharged on the same day.It was further reported that on (b)(6) 2020, mri was performed to the subject, which revealed long segment occlusion of the right sfa proximally to the stent length with clinical signs of peripheral arterial occlusive disease (paod) iib.On (b)(6) 2020, 100% occlusion noted in the right sfa was recanalized with a bern catheter and guidewire followed by multiple dilatations with a 6 x 22 mm sterling balloon catheter in the long segment and dilatation with a 5 x 100 mm drug-coated ranger catheter.Proximal residual stenosis was dilated with a 7 x 40 mm sterling balloon catheter.Due to the persistent rigid stenosis, stenting was performed with a 6 x 150 mm self expanding innova stent, followed by post-dilation with a 6 x 22 mm sterling balloon catheter, and then further stenting with a 6 x 120 mm innova stent.

Event Description

Imperial clinical study it was reported that in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was in the right distal superficial femoral artery (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 6 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with pre-dilatation and a placement of a 6 mm x 100 mm study stent.Following post-dilatation, residual stenosis was 0%.Subsequently, a 6 mm x 100 mm stent was opened but not inserted.On (b)(6) 2016 the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020 1575 days post index procedure, the subject was noted to have in-stent stenosis.Subsequently subject was hospitalized for further evaluation and treatment.100% in-stent stenosis was noted in the right sfa.It was treated by percutaneous transluminal angioplasty (pta) (stenting with 2 stents, dilation with drug coated balloon.Following post dilation, the residual stenosis was 10%.On (b)(6) 2020, the event was considered to be resolved with residual effects and the subject was discharged on the same day.It was further reported that on (b)(6) 2020, mri was performed to the subject, which revealed long segment occlusion of the right sfa proximally to the stent length with clinical signs of peripheral arterial occlusive disease (paod) iib.On (b)(6) 2020, 100% occlusion noted in the right sfa was recanalized with a bern catheter and guidewire followed by multiple dilatations with a 6 x 22 mm sterling balloon catheter in the long segment and dilatation with a 5 x 100 mm drug-coated ranger catheter.Proximal residual stenosis was dilated with a 7 x 40 mm sterling balloon catheter.Due to the persistent rigid stenosis, stenting was performed with a 6 x 150 mm self expanding innova stent, followed by post-dilation with a 6 x 22 mm sterling balloon catheter, and then further stenting with a 6 x 120 mm innova stent.It was further reported that on (b)(6) 2020, mri of the right leg was performed which revealed tandem stenosis in the proximal deep femoral artery main stem.Stretch of occlusion was noted in the proximal course a few centimeters after the bifurcation over 21 cm in the sfa.The popliteal artery, tibiofibular tract, and triple vessel supply of the lower leg with two vessels passing the ankle joint appeared to be normal.The anterior tibial artery showed an outflow stenosis of 50% and a second highest grade, subtotal stenosis over the proximal course.On (b)(6) 2020, angiography revealed high grade stenosis in the right sfa proximally to the stent placed in 2016 and in-stent stenosis in the old stent.A 0.018 inch guidewire was used.Post-balloon angioplasty, residual stenosis was noted in particular at the start of the former occlusion as well as in the stent.Following post-dilation, the residual stenosis was 10%.A post-interventional treadmill test was performed, which appeared normal.Tingling and feeling of numbness in the right foot were present.Subject was noted to have elevation in the serum creatinine for which angiography was postponed from (b)(6) 2020.

Event Description

Imperial clinical study.It was reported that in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was in the right distal superficial femoral artery (sfa) with 100% stenosis and was 80 mm long with a proximal reference vessel diameter of 6 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.The target lesion was treated with pre-dilatation and a placement of a 6 mm x 100 mm study stent.Following post-dilatation, residual stenosis was 0%.Subsequently, a 6 mm x 100 mm stent was opened but not inserted.On (b)(6) 2016 the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020 1575 days post index procedure, the subject was noted to have in-stent stenosis.Subsequently subject was hospitalized for further evaluation and treatment.100% in-stent stenosis was noted in the right sfa.It was treated by percutaneous transluminal angioplasty (pta) (stenting with 2 stents, dilation with drug coated balloon.Following post dilation, the residual stenosis was 10%.On (b)(6) 2020, the event was considered to be resolved with residual effects and the subject was discharged on the same day.It was further reported that on (b)(6) 2020, mri was performed to the subject, which revealed long segment occlusion of the right sfa proximally to the stent length with clinical signs of peripheral arterial occlusive disease (paod) iib.On (b)(6) 2020, 100% occlusion noted in the right sfa was recanalized with a bern catheter and guidewire followed by multiple dilatations with a 6 x 22 mm sterling balloon catheter in the long segment and dilatation with a 5 x 100 mm drug-coated ranger catheter.Proximal residual stenosis was dilated with a 7 x 40 mm sterling balloon catheter.Due to the persistent rigid stenosis, stenting was performed with a 6 x 150 mm self expanding innova stent, followed by post-dilation with a 6 x 22 mm sterling balloon catheter, and then further stenting with a 6 x 120 mm innova stent.It was further reported that on (b)(6) 2020, mri of the right leg was performed which revealed tandem stenosis in the proximal deep femoral artery main stem.Stretch of occlusion was noted in the proximal course a few centimeters after the bifurcation over 21 cm in the sfa.The popliteal artery, tibiofibular tract, and triple vessel supply of the lower leg with two vessels passing the ankle joint appeared to be normal.The anterior tibial artery showed an outflow stenosis of 50% and a second highest grade, subtotal stenosis over the proximal course.On (b)(6) 2020, angiography revealed high grade stenosis in the right sfa proximally to the stent placed in 2016 and in-stent stenosis in the old stent.A 0.018 inch guidewire was used.Post-balloon angioplasty, residual stenosis was noted in particular at the start of the former occlusion as well as in the stent.Following post-dilation, the residual stenosis was 10%.A post-interventional treadmill test was performed, which appeared normal.Tingling and feeling of numbness in the right foot were present.Subject was noted to have elevation in the serum creatinine for which angiography was postponed from (b)(6) 2020 to (b)(6) 2020.It was further reported that follow-up core-lab angiography finding dated november 03, 2020 noted grade 0 thrombus, absence of aneurysm, and presence of in-stent restenosis pattern 4.No stent deformation or stent fracture was noted.

• Brand Name: ELUVIATM 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: 10860664
• MDR Text Key: 216862209
• Report Number: 2134265-2020-15997
• 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,Followup
• Report Date: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018779191
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 63 YR