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 High Blood Pressure/ Hypertension (1908); Occlusion (1984); Pain (1994); Thrombosis (2100)

Event Date 10/01/2018

Event Type  Injury  

Manufacturer Narrative

Date of event was approximated based on the report of (b)(6) 2018.Initial reporter facility name: center for diagnostic radiology and minimally invasive therapy.

Event Description

It was reported that the subject experienced re-occlusion of the study stent.The patient was enrolled in the imperial clinical study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left distal superficial femoral artery (sfa) with 80% stenosis and was 100mm long.It had a proximal reference vessel diameter of 5mm and distal vessel diameter of 5mm and was classified as tasc ii b lesion.The target lesion was treated with placement of a 6.0 x 120mm eluviatm drug-eluting vascular stent system.Following post -dilation residual stenosis was 0%.On (b)(6) 2016, the patient was discharged with dual antiplatelet therapy.On an unknown date in (b)(6) 2018, the patient presented with complaint of pain in both legs.The patient was also noted to have a high blood pressure profile.The patient was hospitalized on the same day for further evaluation.On (b)(6) 2018 the patient underwent color duplex ultrasound of both legs.The left sfa had filiform flow with rapid systolic upstroke from proximally until the middle of the thigh.From the middle of the thigh in the stent until distally, it was occluded for a length of approximately 15cm.Refilling was noted at the popliteal artery.The tibial-fibular trunk had filiform flow consistent with moderately severe stenosis.Strong flow was noted in the fibular artery.On (b)(6) 2018, the patient underwent digital subtraction angiography (dsa) of the left leg arteries which revealed subacute extensive occlusion of the superficial femoral artery and stent thrombosis.In response to the occlusion of the study stent in the left sfa, the patient was treated as in-patient with prostavasin for seven days.An intervention was not recommended for the patient.On (b)(6) 2018, due to dubious exertion induced dyspnea symptoms, the patient underwent transthoracic echocardiogram revealed no wall motion disturbances with good left ventricular ejection fraction (lvef).On (b)(6) 2018, the patient experienced nocturnal rest pains, consistent with polyneuropathy and differential diagnosis restless legs syndrome.The patient was placed on an increased dose of gabapentin in response to the event.On (b)(6) 2018, the symptoms were noted to be improved and the patient was discharged on the same day.On (b)(6) 2019 the patient was diagnosed with an occluded stent and on the same day the patient was hospitalized.On (b)(6) 2019 the patient was discharged.

Event Description

It was reported that the subject experienced re-occlusion of the study stent.The patient was enrolled in the imperial clinical study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left distal superficial femoral artery (sfa) with 80% stenosis and was 100mm long.It had a proximal reference vessel diameter of 5mm and distal vessel diameter of 5mm and was classified as tasc ii b lesion.The target lesion was treated with placement of a 6.0 x 120mm eluviatm drug-eluting vascular stent system.Following post -dilation residual stenosis was 0%.On (b)(6) 2016, the patient was discharged with dual antiplatelet therapy.On an unknown date in (b)(6) 2018, the patient presented with complaint of pain in both legs.The patient was also noted to have a high blood pressure profile.The patient was hospitalized on the same day for further evaluation.On (b)(6) 2018 the patient underwent color duplex ultrasound of both legs.The left sfa had filiform flow with rapid systolic upstroke from proximally until the middle of the thigh.From the middle of the thigh in the stent until distally, it was occluded for a length of approximately 15cm.Refilling was noted at the popliteal artery.The tibial-fibular trunk had filiform flow consistent with moderately severe stenosis.Strong flow was noted in the fibular artery.On (b)(6) 2018, the patient underwent digital subtraction angiography (dsa) of the left leg arteries which revealed subacute extensive occlusion of the superficial femoral artery and stent thrombosis.In response to the occlusion of the study stent in the left sfa, the patient was treated as in-patient with prostavasin for seven days.An intervention was not recommended for the patient.On (b)(6) 2018, due to dubious exertion induced dyspnea symptoms, the patient underwent transthorasic echocardiogram revealed no wall motion disturbances with good left ventricular ejection fraction (lvef).On (b)(6) 2018, the patient experienced nocturnal rest pains, consistent with polyneuropathy and differential diagnosis restless legs syndrome.The patient was placed on an increased dose of gabapentin in response to the event.On (b)(6) 2018, the symptoms were noted to be improved and the patient was discharged on the same day.On (b)(6) 2019 the patient was diagnosed with an occluded stent and on the same day the patient was hospitalized.On (b)(6) 2019 the patient was discharged.It was further reported that on (b)(6) 2019 the subject presented for follow up with complaints of claudication in both right and left calf.Color coded duplex ultrasound of the left leg revealed occlusion of the sfa in the middle third of the vessel with refilling of the femoropopliteal transition and downstream perfusion deficit.Based on the findings, the subject was recommended for vascular surgery in the near future.On (b)(6) 2019 the subject presented for evaluation of the femoral popliteal bypass system on the left side.Angiography revealed that the stent that was placed during the index procedure, in the sfa of the left leg, was occluded.As the subject was noted to have a history of hypertension and dyspnea on exertion, the subject was recommended to undergo blood pressure adjustment and cardiac clarification.Since there was no express claudication symptoms noted in the calves or any pain at rest and the subject was noted to have a history of congestive heart failure (chf), the femoral-popliteal bypass was not recommended.The subject discharge date was changed to (b)(6) 2019 from (b)(6) 2019.The event was considered resolved with sequelae and the subject was discharged on (b)(6) 2019.

Manufacturer Narrative

B3: date of event was approximated based on the report of (b)(6) 2018.(b)(6).

• 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: 8813143
• MDR Text Key: 151774972
• Report Number: 2134265-2019-08342
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018765486
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 80 YR