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 Problems Reocclusion (1985); Thrombosis (2100)

Event Date 04/24/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that an occlusion occurred.The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion 1 was located in the right mid superficial femoral artery (sfa) extending to the right distal sfa with 99% stenosis and was 110 mm long with a proximal reference vessel diameter of 6.00mm and distal vessel diameter 6.00mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 7mmx150mm study stent.Following post-dilatation, stenosis was 0%.On (b)(6) 2017, right leg sfa restenosis, 2 cm distal edge of the stent in the sfa.On (b)(6) 2019, the patient presented to the hospital with chief complaint of shortness of breath and was diagnosed with acute on chronic chf and was hospitalized for further evaluation.The patient was treated with medications.On (b)(6) 2019, the event was resolved and the patient was discharged from the hospital on the same day.On (b)(6) 2019, the patient presented to ed with the complaints of right leg pain and dus of bilateral lower extremity revealed: right leg - 118 cm/s at cfa with monophasic flow; 524 cm/s at profunda femoral artery; study stent in sfa is occluded; monophasic flow was noted in popliteal artery; monophasic flow in anterior and posterior tibial artery which was dampened in dorsalis pedis.The left leg revealed 134 cm/s at cfa with multiphasic flow; a tent profunda artery with 147 cm/s velocity; patent sfa stent with 127-220 cm/s velocity at proximal sfa; 140-155 cm/s velocity at mid to distal sfa; 107-234 cm/s velocity at popliteal artery; biphasic to mophasic fow at anterior and posterior tibial artery.The patient was diagnosed with occlusion of the right sfa including the stent that was implanted during the index procedure.The patient was hospitalized for the possible intervention and further evaluation.On (b)(6) 2019, 891 days post index procedure, 100% of the occlusion noted in the right sfa was treated with mechanical aspiration with arthrectomy, cross and cutting balloon angioplasty(tvr) with 0% residual stenosis.On (b)(6) 2019, the event was considered resolved and the patient was discharged the same day.

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that an occlusion occurred.The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion 1 was located in the right mid superficial femoral artery (sfa) extending to the right distal sfa with 99% stenosis and was 110 mm long with a proximal reference vessel diameter of 6.00mm and distal vessel diameter 6.00mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 7mmx150mm study stent.Following post-dilatation, stenosis was 0%.On (b)(6) 2017, right leg sfa restenosis, 2 cm distal edge of the stent in the sfa.On (b)(6) 2019, the patient presented to the hospital with chief complaint of shortness of breath and was diagnosed with acute on chronic chf and was hospitalized for further evaluation.The patient was treated with medications.On (b)(6) 2019, the event was resolved and the patient was discharged from the hospital on the same day.On (b)(6) 2019, the patient presented to ed with the complaints of right leg pain and dus of bilateral lower extremity revealed: right leg - 118 cm/s at cfa with monophasic flow; 524 cm/s at profundafemoral artery; study stent in sfa is occluded; monophasic flow was noted in popliteal artery; monophasic flow in anterior and posterior tibial artery which was dampened in dorsalis pedis.The left leg revealed 134 cm/s at cfa with multiphasic flow; atent profunda artery with 147 cm/s velocity; patent sfa stent with 127-220 cm/s velocity at proximal sfa; 140-155 cm/s velocity at mid to distal sfa; 107-234 cm/s velocity at popliteal artery; biphasic to mophasic fow at anterior and posterior tibial artery.The patient was diagnosed with occlusion of the right sfa including the stent that was implanted during the index procedure.The patient was hospitalized for the possible intervention and further evaluation.On (b)(6) 2019, 891 days post index procedure, 100% of the occlusion noted in the right sfa was treated with mechanical aspiration with athrectomy, cross and cutting balloon angioplasty(tvr) with 0% residual stenosis.On (b)(6) 2019, the event was considered resolved and the patient was discharged the same day.Additional information stated that follow-up core-lab angiography finding dated (b)(6) 2019 noted thrombus of grade 0 and absence of aneurysm.However, core lab noted the presence of in-stent restenosis (isr) pattern 4.No stent deformation or stent fracture was noted.

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that an occlusion occurred.The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion 1 was located in the right mid superficial femoral artery (sfa) extending to the right distal sfa with 99% stenosis and was 110 mm long with a proximal reference vessel diameter of 6.00mm and distal vessel diameter 6.00mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 7mmx150mm study stent.Following post-dilatation, stenosis was 0%.On (b)(6) 2017 right leg sfa restenosis, 2 cm distal edge of the stent in the sfa.On (b)(6) 2019 the patient presented to the hospital with chief complaint of shortness of breath and was diagnosed with acute on chronic chf and was hospitalized for further evaluation.The patient was treated with medications.On (b)(6) 2019 the event was resolved and the patient was discharged from the hospital on the same day.On (b)(6) 2019 the patient presented to ed with the complaints of right leg pain and dus of bilateral lower extremity revealed: right leg - 118 cm/s at cfa with monophasic flow; 524 cm/s at profundafemoral artery; study stent in sfa is occluded; monophasic flow was noted in popliteal artery; monophasic flow in anterior and posterior tibial artery which was dampened in dorsalis pedis.The left leg revealed 134 cm/s at cfa with multiphasic flow; latent profunda artery with 147 cm/s velocity; patent sfa stent with 127-220 cm/s velocity at proximal sfa; 140-155 cm/s velocity at mid to distal sfa; 107-234 cm/s velocity at popliteal artery; biphasic to mophasic flow at anterior and posterior tibial artery.The patient was diagnosed with occlusion of the right sfa including the stent that was implanted during the index procedure.The patient was hospitalized for the possible intervention and further evaluation.On (b)(6) 2019 891 days post index procedure, 100% of the occlusion noted in the right sfa was treated with mechanical aspiration with arthrectomy, cross and cutting balloon angioplasty(tvr) with 0% residual stenosis.On (b)(6) 2019 the event was considered resolved and the patient was discharged the same day.Additional information stated that follow-up core-lab angiography finding dated (b)(6) 2019 noted thrombus of grade 0 and absence of aneurysm.However, core lab noted the presence of in-stent restenosis (isr) pattern 4.No stent deformation or stent fracture was noted.Additional information noted that on (b)(6) 2019 angiography revealed that in the right leg there was no significant disease in common iliac artery, external iliac artery and common femoral artery; severe diffusely disease in the profunda artery; 100% in stent stenosis in the sfa; widely patent stent (unknown manufacturer) in the popliteal artery; severely diffused anterior tibial artery tibio peroneal trunk; posterior tibial artery and peroneal artery.In the left leg it showed no significant disease in common iliac, external iliac and common femoral artery; severe diffusely disease in profunda artery; 70% in-stent stenosis (unknown manufacture) in sfa and 80% stenosis in the popliteal artery.On the same day, the in-stent stenosis noted in the study stent was treated.Per the discharge summary, it was noted that the patient had a vasovagal episode during the hospitalization stay with no syncopal episodes.Additionally, it was confirmed that the patient had angioplasty of the right anterior tibial, right dorsalis pedis, posterior tibialis and balloon angioplasty of the popliteal artery on (b)(6) 2018.Additional information noted that the event was classified as stent thrombosis.On (b)(6) 2019, the % in-stent thrombotic occlusion noted in the right sfa was treated by performing thrombolysis, mechanical aspiration with atherectomy, cutting balloon angioplasty with 0% residual stenosis.

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that an occlusion occurred.The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion 1 was located in the right mid superficial femoral artery (sfa) extending to the right distal sfa with 99% stenosis and was 110 mm long with a proximal reference vessel diameter of 6.00mm and distal vessel diameter 6.00mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 7mmx150mm study stent.Following post-dilatation, stenosis was 0%.On (b)(6) 2017 right leg sfa restenosis, 2 cm distal edge of the stent in the sfa.On (b)(6) 2019 the patient presented to the hospital with chief complaint of shortness of breath and was diagnosed with acute on chronic chf and was hospitalized for further evaluation.The patient was treated with medications.On (b)(6) 2019 the event was resolved and the patient was discharged from the hospital on the same day.On (b)(6) 2019 the patient presented to emergency department with the complaints of right leg pain and dus of bilateral lower extremity revealed: right leg - 118 cm/s at cfa with monophasic flow; 524 cm/s at profundafemoral artery; study stent in sfa is occluded; monophasic flow was noted in popliteal artery; monophasic flow in anterior and posterior tibial artery which was dampened in dorsalis pedis.The left leg revealed 134 cm/s at cfa with multiphasic flow; latent profunda artery with 147 cm/s velocity; patent sfa stent with 127-220 cm/s velocity at proximal sfa; 140-155 cm/s velocity at mid to distal sfa; 107-234 cm/s velocity at popliteal artery; biphasic to mophasic flow at anterior and posterior tibial artery.The patient was diagnosed with occlusion of the right sfa including the stent that was implanted during the index procedure.The patient was hospitalized for the possible intervention and further evaluation.On (b)(6) 2019 891 days post index procedure, 100% of the occlusion noted in the right sfa was treated with mechanical aspiration with arthrectomy, cross and cutting balloon angioplasty(tvr) with 0% residual stenosis.On (b)(6) 2019 the event was considered resolved and the patient was discharged the same day.Additional information stated that follow-up core-lab angiography finding dated april 25, 2019 noted thrombus of grade 0 and absence of aneurysm.However, core lab noted the presence of in-stent restenosis (isr) pattern 4.No stent deformation or stent fracture was noted.Additional information noted that on april 25, 2019, angiography revealed that in the right leg there was no significant disease in common iliac artery, external iliac artery and common femoral artery; severe diffusely disease in the profunda artery; 100% in stent stenosis in the sfa; widely patent stent (unknown manufacturer) in the popliteal artery; severely diffused anterior tibial artery tibio peroneal trunk; posterior tibial artery and peroneal artery.In the left leg it showed no significant disease in common iliac, external iliac and common femoral artery; severe diffusely disease in profunda artery; 70% in-stent stenosis (unknown manufacture) in sfa and 80% stenosis in the popliteal artery.On the same day, the in-stent stenosis noted in the study stent was treated.Per the discharge summary, it was noted that the patient had a vasovagal episode during the hospitalization stay with no syncopal episodes.Additionally, it was confirmed that the patient had angioplasty of the right anterior tibial, right dorsalis pedis, posterior tibialis and balloon angioplasty of the popliteal artery on (b)(6) 2018.

• 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: 8613221
• MDR Text Key: 145163810
• Report Number: 2134265-2019-05262
• 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,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018822222
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR