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 Fatigue (1849); Muscle Weakness (1967); Pain (1994); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 08/30/2017

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6) at the time of study enrollment.

Event Description

It was reported that stent occlusion occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the right mid superficial femoral artery (sfa) with 90% stenosis.The target lesion was 75 mm long with a proximal reference vessel diameter of 5.00 mm and a distal reference vessel diameter of 5.00 mm.It was classified as a tasc ii b lesion.The target lesion was treated with direct placement of a 6 mm x 80 mm study stent and a 6 mm x 60 mm study stent in an overlapping manner.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the subject was discharged with aspirin and clopidogrel.On (b)(6) 2017, the subject visited the hospital for study-specific 12 month follow up.During the visit, the subject had complaint of intermittent bilateral claudication, joint pain, limb pain, and left lower extremity weakness with difficulty in walking; however, no rest pain.On the same day, lower extremity ankle brachial index (abi) / pulse volume recording (pvr) was performed which revealed: moderately decreased perfusion of the right lower extremity and normal perfusion of the left lower extremity to the ankle but moderately to severely decreased at the pedal artery level.Right femur radiographs performed on the same day revealed atherosclerotic calcification with a vascular stent in the medial thigh.No bony destruction or erosion.Severe knee osteoarthritis was partially visualized and minimal right hip osteoarthrosis was noted.On the same day, 411 days post index procedure, lower extremities arterial duplex imaging was performed which revealed: right lower extremity: proximally occluded right mid sfa stent, hemodynamically significant stenosis (75-99%) in right mid popliteal artery and proximal peroneal artery and occluded right posterior tibial artery (pta) and anterior tibial artery (ata).Right common femoral artery and distal femoral artery was noted to be patent.Left lower extremity: occluded left posterior tibial artery (pta) and mid anterior tibial artery (ata), mild to moderate stenosis of the left mid sfa, proximal popliteal artery and proximal peroneal artery.Left common femoral artery (cfa) and distal femoral artery (dfa) were noted to be patent.Based on these findings, the subject was recommended for a follow up and further work up in 6 months for left lower extremity pain.The subject was recommended for a follow up and angiogram sooner in case of his right limb was bothersome or had limited his daily activities.On (b)(6) 2018, the subject visited the hospital for follow up.During the visit, the subject had a complaint of bilateral posterior knee pain and had difficulty in walking at about 3-4 blocks due to overall fatigue.The subject denied presence of any calf claudication, rest pain, non-healing sores, or wounds and any focal neurological deficits.On the same day, lower extremity arterial duplex imaging was performed which was noted to be consistent with the findings from duplex imaging performed on (b)(6) 2017.The subject was recommended to follow up with orthopedic for pain behind the knees.The subject was also recommended to proceed with revascularization for his lower extremity pain if orthopedic work up was found to be negative.On (b)(6) 2021, the subject visited the hospital for study specific 60 month follow up and subsequently, underwent right lower extremities arterial duplex which revealed occluded right sfa, occluded proximal and mid right posterior tibial artery, moderate stenosis of the right mid popliteal artery and mild stenosis of the profunda artery and occlusion of the right sfa stent.No action was taken in response to the event.However, the subject had been taking aspirin, lipitor but no plavix.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13257933
• MDR Text Key: 284008325
• Report Number: 2134265-2022-00188
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2022
• 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: 0018731611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/29/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Ethnicity: Hispanic