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 Pain (1994); Thrombosis (2100)

Event Date 12/10/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination device.

Event Description

It was reported that thrombosis 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 was located in the right leg distal superficial femoral artery (sfa) with 85% stenosis and was 35mm long with a proximal reference vessel diameter of 5.00mm and distal vessel diameter of 5.00mm and was classified as tasc ii d lesion.The lesion was treated with pre-dilatation and placement of a 7.0 x60mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2018, the subject presented with the complaints of bilateral leg pain.Subsequently, the subject was hospitalized on the same day for further evaluation.On the same day, subject underwent arterial ultrasound which revealed, occlusion in right common femoral artery with no flow below common femoral artery; high grade stenosis in left common femoral artery with minim flow in anterior tibial artery and no flow in dorsalis pedis or posterior tibial artery.On (b)(6) 2018, the subject underwent abdominal aortogram and bilateral lower extremity angiography which revealed distal aortic occlusion equivalent with bilateral common iliac artery occlusion.Given the appearance of the lower extremity, decision was made to perform iliac reconstruction.On the same day a 14 x 60 mm non-bsc stent and 8 x 37 mm express stents were placed in the distal aorta to the right common iliac artery.Runoff of the right lower extremity demonstrates flow into the right deep femoral artery with component of compromise right sfa; on the left side, minimal flow was seen up to the level of left deep femoral artery based on anatomy and continued poor runoff, bilateral lower extremity thrombolysis was initiated.On (b)(6) 2018, the subject underwent abdominal aortogram and bilateral lower extremity angiography which revealed distal aortic was patent; patent common external iliac arteries; partial occlusion of the right profundal femoral artery; total occlusion of right sfa without reconstitution of distal arteries at the lower extremity; left profundal femoral and common femoral artery were patent; reconstitution of flow in the distal left sfa and popliteal artery.As the right leg continued to be cold and mottled, the subject was recommended for below the knee amputation of right leg.On (b)(6) 2018, the event was considered recovered and resolved and the patient was discharged on the same day.

Manufacturer Narrative

Device is a combination device.

Event Description

It was reported that thrombosis 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 was located in the right leg distal superficial femoral artery (sfa) with 85% stenosis and was 35mm long with a proximal reference vessel diameter of 5.00mm and distal vessel diameter of 5.00mm and was classified as tasc ii d lesion.The lesion was treated with pre-dilatation and placement of a 7.0 x60mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2018, the subject presented with the complaints of bilateral leg pain.Subsequently, the subject was hospitalized on the same day for further evaluation.On the same day, subject underwent arterial ultrasound which revealed, occlusion in right common femoral artery with no flow below common femoral artery; high grade stenosis in left common femoral artery with minim flow in anterior tibial artery and no flow in dorsalis pedis or posterior tibial artery.On (b)(6) 2018, the subject underwent abdominal aortogram and bilateral lower extremity angiography which revealed distal aortic occlusion equivalent with bilateral common iliac artery occlusion.Given the appearance of the lower extremity, decision was made to perform iliac reconstruction.On the same day a 14 x 60 mm non-bsc stent and 8 x 37 mm express stents were placed in the distal aorta to the right common iliac artery.Runoff of the right lower extremity demonstrates flow into the right deep femoral artery with component of compromise right sfa; on the left side, minimal flow was seen up to the level of left deep femoral artery based on anatomy and continued poor runoff, bilateral lower extremity thrombolysis was initiated.On (b)(6) 2018, the subject underwent abdominal aortogram and bilateral lower extremity angiography which revealed distal aortic was patent; patent common external iliac arteries; partial occlusion of the right profundal femoral artery; total occlusion of right sfa without reconstitution of distal arteries at the lower extremity; left profundal femoral and common femoral artery were patent; reconstitution of flow in the distal left sfa and popliteal artery.As the right leg continued to be cold and mottled, the subject was recommended for below the knee amputation of right leg.On (b)(6) 2018, the event was considered recovered and resolved and the patient was discharged on the same day.Additional information reported that on (b)(6) 2018, the patient underwent above the knee amputation and embolectomy of the right sfa.Follow up core lab angiography finding dated (b)(6) 2018 noted thrombus of unknown and ansence of aneurysm.However, core lab noted the presence of isr pattern 4.Additional information reported that on (b)(6) 2019, the patient died of an unknown cause.It is not reported if the death is related to the eluvia device.

Manufacturer Narrative

Device is a combination device.

Event Description

It was reported that thrombosis 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 was located in the right leg distal superficial femoral artery (sfa) with 85% stenosis and was 35mm long with a proximal reference vessel diameter of 5.00mm and distal vessel diameter of 5.00mm and was classified as tasc ii d lesion.The lesion was treated with pre-dilatation and placement of a 7.0 x60mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2018, the subject presented with the complaints of bilateral leg pain.Subsequently, the subject was hospitalized on the same day for further evaluation.On the same day, subject underwent arterial ultrasound which revealed, occlusion in right common femoral artery with no flow below common femoral artery; high grade stenosis in left common femoral artery with minim flow in anterior tibial artery and no flow in dorsalis pedis or posterior tibial artery.On (b)(6) 2018, the subject underwent abdominal aortogram and bilateral lower extremity angiography which revealed distal aortic occlusion equivalent with bilateral common iliac artery occlusion.Given the appearance of the lower extremity, decision was made to perform iliac reconstruction.On the same day a 14 x 60 mm non-bsc stent and 8 x 37 mm express stents were placed in the distal aorta to the right common iliac artery.Runoff of the right lower extremity demonstrates flow into the right deep femoral artery with component of compromise right sfa; on the left side, minimal flow was seen up to the level of left deep femoral artery based on anatomy and continued poor runoff, bilateral lower extremity thrombolysis was initiated.On (b)(6) 2018, the subject underwent abdominal aortogram and bilateral lower extremity angiography which revealed distal aortic was patent; patent common external iliac arteries; partial occlusion of the right profundal femoral artery; total occlusion of right sfa without reconstitution of distal arteries at the lower extremity; left profundal femoral and common femoral artery were patent; reconstitution of flow in the distal left sfa and popliteal artery.As the right leg continued to be cold and mottled, the subject was recommended for below the knee amputation of right leg.On (b)(6) 2018, the event was considered recovered and resolved and the patient was discharged on the same day.Additional information reported that on (b)(6) 2018, the patient underwent above the knee amputation and embolectomy of the right sfa.Follow up core lab angiography finding dated (b)(6) 2018 noted thrombus of unknown and ansence of aneurysm.However, core lab noted the presence of isr pattern 4.Additional information reported that on (b)(6) 2019, the patient died of an unknown cause.It is not reported if the death is related to the eluvia device.Additional information reported that per edc and death certificate, the immediate cause of death was noted to be "myocardial infarction." other significant conditions contributing to death was coronary artery disease, hypertension, diabetes mellitus and chronic kidney disease.No autopsy was performed.

• 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: 8246957
• MDR Text Key: 133037162
• Report Number: 2134265-2019-00031
• 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
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018731615
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2018
• Initial Date FDA Received: 01/15/2019
• Supplement Dates Manufacturer Received: 02/21/2019; 03/12/2019
• Supplement Dates FDA Received: 03/05/2019; 03/26/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 77 YR