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 Pain (1994); Movement Disorder (4412); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 01/24/2022

Event Type  Injury  

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis and was 35 mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 4.4 mm and was classified as transatlantic intersociety consensus (tasc) ii a lesion.Target lesion was pre-dilated and treated with placement of a 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medication.On (b)(6) 2022, 1231 days post index procedure, the subject presented with unknown symptoms and was diagnosed with in-stent stenosis right femoral artery.No further recommendations or actions were taken to treat the event.

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled in the eminent study on 11-sep-2018 and the index procedure was performed on the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis and was 35mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 4.4 mm and was classified as transatlantic intersociety consensus (tasc) ii a lesion.Target lesion was pre-dilated and treated with placement of a 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.On 11-sep-2018, the subject was discharged with antiplatelet medication.On 24-jan-2022, 1231 days post index procedure, the subject presented with unknown symptoms and was diagnosed with in-stent stenosis right femoral artery.No further recommendations or actions were taken to treat the event.It was further reported that on (b)(6) 2022, the patient was admitted to the hospital for further evaluation and treatment.It was noted that the lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis, however the lesion length had increased to 170mm.The 100% stenosed target lesion in the right mid sfa with lesion length 170 mm and reference vessel diameter of 4.8 mm was treated with percutaneous transluminal angioplasty followed with an additional stent placement.Post-treatment, 25% residual stenosis was noted, and no thrombus was seen.The event was considered recovering/ resolving.The patient was discharged the same day.

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis and was 35mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 4.4 mm and was classified as transatlantic intersociety consensus (tasc) ii a lesion.Target lesion was pre-dilated and treated with placement of a 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medication.On 24-jan-2022, 1231 days post index procedure, the subject presented with unknown symptoms and was diagnosed with in-stent stenosis right femoral artery.No further recommendations or actions were taken to treat the event.It was further reported that on (b)(6) 2022, the patient was admitted to the hospital for further evaluation and treatment.It was noted that the lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis, however the lesion length had increased to 170mm.The 100% stenosed target lesion in the right mid sfa with lesion length 170 mm and reference vessel diameter of 4.8 mm was treated with percutaneous transluminal angioplasty followed with an additional stent placement.Post-treatment, 25% residual stenosis was noted, and no thrombus was seen.The event was considered recovering/ resolving.The patient was discharged the same day.It was further reported that clarified previous information that the unknown symptoms were severe problems in walking, pain and moderate problems while performing the usual activities.The hospital admitted date was updated from (b)(6) 2022, 1291 days post-procedure where the patient was treated with recanalization of entire trajectory and dilation with 5mm.Later, control angiographically showed some improvement, still a restenosis proximal in the sfa and extensive calcifications in stenosis in the distal sfa were noted.Therefore, the stent was extended distally with a self-expandable innova 6 x 150 mm stent followed by dilation of the proximal restenosis with 5 mm balloon were performed.

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis and was 35mm long with a proximal reference vessel diameter of 5 mm and a distal reference vessel diameter of 4.4 mm and was classified as transatlantic intersociety consensus (tasc) ii a lesion.Target lesion was pre-dilated and treated with placement of a 6 mm x 120 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medication.On (b)(6) 2022, 1231 days post index procedure, the subject presented with unknown symptoms and was diagnosed with in-stent stenosis right femoral artery.No further recommendations or actions were taken to treat the event.It was further reported that on (b)(6) 2022, the patient was admitted to the hospital for further evaluation and treatment.It was noted that the lesion was located in the right mid superficial femoral artery (sfa) with 100% stenosis, however the lesion length had increased to 170mm.The 100% stenosed target lesion in the right mid sfa with lesion length 170 mm and reference vessel diameter of 4.8 mm was treated with percutaneous transluminal angioplasty followed with an additional stent placement.Post-treatment, 25% residual stenosis was noted, and no thrombus was seen.The event was considered recovering/ resolving.The patient was discharged the same day.It was further reported that clarified previous information that the unknown symptoms were severe problems in walking, pain and moderate problems while performing the usual activities.The hospital admitted date was updated from (b)(6) 2022 to (b)(6) 2022, 1291 days post-procedure where the patient was treated with recanalization of entire trajectory and dilation with 5mm.Later, control angiographically showed some improvement, still a restenosis proximal in the sfa and extensive calcifications in stenosis in the distal sfa were noted.Therefore, the stent was extended distally with a self-expandable innova 6 x 150 mm stent followed by dilation of the proximal restenosis with 5 mm balloon were performed.It was further reported that the symptoms of severe problems in walking, pain and moderate problems while performing the usual activities have all been reduced to just claudication.Physical examination revealed warm feet, however good pulse was noted in the groin region.During this time, the clinical symptom stage was noted to be fontaine iib.On (b)(6) 2022, duplex of right limb revealed stenosis in the stent with proximal ratio 10.5 = 75 - 99 %.The subject was diagnosed with in-stent stenosis of right superficial femoral artery hence, was recommended to undergo interventional procedure as a treatment for this event.On (b)(6) 2022, the subject presented at the outpatient clinic and improvement in right limb was noted.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13672481
• MDR Text Key: 286637789
• Report Number: 2134265-2022-01647
• 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: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/27/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022247651
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 63 YR
• Patient Sex: Male
• Patient Race: White