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); Numbness (2415); Embolism/Embolus (4438); Thrombosis/Thrombus (4440); Restenosis (4576)

Event Date 02/25/2022

Event Type  Injury  

Event Description

Eminent clinical study: it was reported that in-stent restenosis and in-stent thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in the right distal superficial femoral artery (sfa) involving proximal popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of 7 mm x 100 mm and 7 mm x 80 mm study stents.Following post dilation, residual stenosis was 10%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1100 days post index procedure, the subject presented to the clinic emergently with complains of pains in the right foot.Clinical findings revealed feeling of numbness and cold right fore foot which was persistent from previous day.On the same day, the subject was hospitalized for further evaluation and treatment.Upon duplex ultrasound examination, performed revealed occlusion of the sfa in the right side.Pronounced thrombus formation in the area of the sfa and popliteal artery.Also, thrombus formations were detected in the proximal section of the sfa next to the sheath.A further smaller thrombus with partial blood flow was detected in segment p3, which was probably an embolism.The subject was recommended to undergo interventional procedure to treat the event.On (b)(6) 2022, 1100 days post index procedure, right mid (target lesion) sfa with 100% stenosis with 200 mm long and a reference vessel diameter of 5 mm, was treated by performing thrombolysis using thrombolysis catheter, 4 mg rtpa per 6 hours was administered.Also, full heparinization via the sheath (target ptt 50-70) was administered.Post-procedure, resulted in 50% of residual stenosis and no thrombus was seen.Additionally, clinical findings showed that leg was warm, and the puncture site was free of any inflammation.Since the residual thrombi on the vessel wall was noted, the use of a drug-coated balloon angioplasty was recommended in approx.8 weeks for an elective pta of the left sfa.During the hospitalization, on the same day the subject was diagnosed with occlusion distal right sfa.For the same, the event led to prolonged hospitalization.On (b)(6) 2022, 1101 days post index procedure, right distal (target lesion) sfa with 50% stenosis with 30 mm long and a reference vessel diameter of 5 mm, was treated by percutaneous transluminal angioplasty using 6 mm balloon.Post procedure, resulted in 0% of residual stenosis and no thrombus was seen.On (b)(6) 2022, the event was resolved, and the subject was discharged on the same day on dual antiplatelet therapy with asa and clopidogrel for two months, then advised monotherapy with asa.

Manufacturer Narrative

Age or date of birth: age at time of event: 77 years old at the time of study enrollment.Initial reporter name and address: facility name: (b)(6).

Manufacturer Narrative

Corrected h6 patient codes.A2: age at time of event: 77 years old at the time of study enrollment.E1: initial reporter facility name: gpoagka klinikum rosenheim institut fur diagnostische und in.

Event Description

Eminent clinical study.It was reported that in-stent restenosis and in-stent thrombosis occurred.The subject was enrolled in the eminent study on 21-feb-2019 and the index procedure was performed on the same day.Target lesion was located in the right distal superficial femoral artery (sfa) involving proximal popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of 7 mm x 100 mm and 7 mm x 80 mm study stents.Following post dilation, residual stenosis was 10%.On 23-feb-2019, the subject was discharged with antiplatelet therapy.On (b)(6)2022, 1100 days post index procedure, the subject presented to the clinic emergently with complains of pains in the right foot.Clinical findings revealed feeling of numbness and cold right fore foot which was persistent from previous day.On the same day, the subject was hospitalized for further evaluation and treatment.Upon duplex ultrasound examination, performed revealed occlusion of the sfa in the right side.Pronounced thrombus formation in the area of the sfa and popliteal artery.Also, thrombus formations were detected in the proximal section of the sfa next to the sheath.A further smaller thrombus with partial blood flow was detected in segment p3, which was probably an embolism.The subject was recommended to undergo interventional procedure to treat the event.On (b)(6)2022, 1100 days post index procedure, right mid (target lesion) sfa with 100% stenosis with 200 mm long and a reference vessel diameter of 5 mm, was treated by performing thrombolysis using thrombolysis catheter, 4 mg rtpa per 6 hours was administered.Also, full heparinization via the sheath (target ptt 50-70) was administered.Post-procedure, resulted in 50% of residual stenosis and no thrombus was seen.Additionally, clinical findings showed that leg was warm, and the puncture site was free of any inflammation.Since the residual thrombi on the vessel wall was noted, the use of a drug-coated balloon angioplasty was recommended in approx.8 weeks for an elective pta of the left sfa.During the hospitalization, on the same day the subject was diagnosed with occlusion distal right sfa.For the same, the event led to prolonged hospitalization.On (b)(6)-2022, 1101 days post index procedure, right distal (target lesion) sfa with 50% stenosis with 30 mm long and a reference vessel diameter of 5 mm, was treated by percutaneous transluminal angioplasty using 6 mm balloon.Post procedure, resulted in 0% of residual stenosis and no thrombus was seen.On (b)(6)2022, the event was resolved, and the subject was discharged on the same day on dual antiplatelet therapy with asa and clopidogrel for two months, then advised monotherapy with asa.It was further reported that on (b)(6)2022, the subject was hospitalized for thrombolytic therapy with 4 mg rtpa per 6 hours via the thrombolysis catheter.Thrombolysis therapy initiated with the antegrade puncture of the right cfa and insertion of a 4f sheath.Using a non-boston scientific wire and a 4f grade catheter, the sfa occlusion was examined.Changed to a 40 cm long thrombolysis catheter up to section pii.It had a sheath attached.Post thrombolysis findings revealed a noticeable thrombus was shown starting around 5 cm above the sfa stent.Due to the thrombus material, which was in section pii, the entire stent was misplaced.Additionally, thrombus material was still present close to the sheath in segment p3 right above the origin of the ata and the proximal part of the sfa.The latter two thrombus forms are both small and have only a limited blood flow.Three veins were responsible for the very slow blood flow in the lower leg.Assessments revealed pronounced thrombus development in the sfa and popliteal artery.The most likely reason was stenosis at the stent inlet.Additionally, thrombus forms were found in the sfa's proximal region, right next to the sheath.There was barely any distal blood flow left, which is probably how this thrombus originated.Segment p3 also has a smaller thrombus with partial blood flow.Most likely, this was an embolism.Following 24-hour thrombolytic therapy, none of the three vessels, the entire sfa, the popliteal artery, and the lower leg were blocked.A short-segment stenosis in the stent itself was found and treated successfully with a 6 mm balloon.There were luminal irregularities associated with small marginal residual thrombi observed in the stent itself and, to some extent, above the stent.Due to the persistent residual thrombi, the subject was invited to come back for a follow-up appointment in around 8 weeks for a repeat pta of the right sfa.

Manufacturer Narrative

Correction: statement within b5 describe event or problem corrected and clarified.A2: age at time of event: 77 years old at the time of study enrollment.E1: initial reporter facility name: (b)(6).

Event Description

Eminent clinical study.It was reported that in-stent restenosis and in-stent thrombosis occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.Target lesion was located in the right distal superficial femoral artery (sfa) involving proximal popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of 7 mm x 100 mm and 7 mm x 80 mm study stents.Following post dilation, residual stenosis was 10%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1100 days post index procedure, the subject presented to the clinic emergently with complains of pains in the right foot.Clinical findings revealed feeling of numbness and cold right fore foot which was persistent from previous day.On the same day, the subject was hospitalized for further evaluation and treatment.Upon duplex ultrasound examination, performed revealed occlusion of the sfa in the right side.Pronounced thrombus formation in the area of the sfa and popliteal artery.Also, thrombus formations were detected in the proximal section of the sfa next to the sheath.A further smaller thrombus with partial blood flow was detected in segment p3, which was probably an embolism.The subject was recommended to undergo interventional procedure to treat the event.On (b)(6) 2022, 1100 days post index procedure, right mid (target lesion) sfa with 100% stenosis with 200 mm long and a reference vessel diameter of 5 mm, was treated by performing thrombolysis using thrombolysis catheter, 4 mg rtpa per 6 hours was administered.Also, full heparinization via the sheath (target ptt 50-70) was administered.Post-procedure, resulted in 50% of residual stenosis and no thrombus was seen.Additionally, clinical findings showed that leg was warm, and the puncture site was free of any inflammation.Since the residual thrombi on the vessel wall was noted, the use of a drug-coated balloon angioplasty was recommended in approx.8 weeks for an elective pta of the left sfa.During the hospitalization, on the same day the subject was diagnosed with occlusion distal right sfa.For the same, the event led to prolonged hospitalization.On (b)(6) 2022, 1101 days post index procedure, right distal (target lesion) sfa with 50% stenosis with 30 mm long and a reference vessel diameter of 5 mm, was treated by percutaneous transluminal angioplasty using 6 mm balloon.Post procedure, resulted in 0% of residual stenosis and no thrombus was seen.On (b)(6) 2022, the event was resolved, and the subject was discharged on the same day on dual antiplatelet therapy with asa and clopidogrel for two months, then advised monotherapy with asa.It was further reported that on (b)(6) 2022, the subject was hospitalized for thrombolytic therapy with 4 mg rtpa per 6 hours via the thrombolysis catheter.Thrombolysis therapy initiated with the antegrade puncture of the right cfa and insertion of a 4f sheath.Using a non-boston scientific wire and a 4f grade catheter, the sfa occlusion was examined.Changed to a 40 cm long thrombolysis catheter up to section pii.It had a sheath attached.Post thrombolysis findings revealed a noticeable thrombus was shown starting around 5 cm above the sfa stent.Due to the thrombus material, which was in section pii, the entire stent was misplaced.Additionally, thrombus material was still present close to the sheath in segment p3 right above the origin of the ata and the proximal part of the sfa.The latter two thrombus forms are both small and have only a limited blood flow.Three veins were responsible for the very slow blood flow in the lower leg.Assessments revealed pronounced thrombus development in the sfa and popliteal artery.The most likely reason was stenosis at the stent inlet.Additionally, thrombus forms were found in the sfa's proximal region, right next to the sheath.There was barely any distal blood flow left, which is probably how this thrombus originated.Segment p3 also has a smaller thrombus with partial blood flow.Most likely, this was an embolism.Following 24-hour thrombolytic therapy, none of the three vessels, the entire sfa, the popliteal artery, and the lower leg were blocked.A short-segment stenosis in the stent itself was found and treated successfully with a 6 mm balloon.There were luminal irregularities associated with small marginal residual thrombi observed in the stent itself and, to some extent, above the stent.Due to the persistent residual thrombi, the subject was invited to come back for a follow-up appointment in around 8 weeks for a repeat pta of the right sfa.It was further reported that the "entire stent was misplaced" is incorrect.The stent was not out of place, but the stent was filled out by thrombus material.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16127976
• MDR Text Key: 306989159
• Report Number: 2124215-2022-55981
• 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,Followup,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/05/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021066743
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Race: White