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 Problem Occlusion (1984)

Event Date 11/03/2017

Event Type  Injury  

Event Description

It was reported that in-stent occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2017 and the index procedure was performed on the same day.The target lesion was located in the left mid superficial femoral artery (sfa) with 100% stenosis.It was 130 mm long with a proximal reference vessel diameter of 4.8 mm and a distal reference vessel diameter of 5.5 mm.It was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation followed by placement of a 6 x 150 mm study stent.Following post-dilation, the residual stenosis was 10%.On (b)(6) 2017, the subject was discharged on antiplatelet therapy.On (b)(6) 2017, the subject was diagnosed with occlusion of the left sfa.No action was taken at the time of diagnosis.On (b)(6) 2017, the subject was hospitalized for further evaluation and treatment.Additional core lab angiography results revealed unknown outflow and patent inflow.In-stent restenosis pattern was occluded with the presence of thrombus and absence of aneurysm.On (b)(6) 2017, the proximal to mid left sfa with 70% stenosis, 50 mm in length, and reference vessel diameter of 5.1 mm was treated with percutaneous transluminal angioplasty (pta), one stent placement proximal to the previously deployed study stent, and thrombolysis.Post-procedure revealed 0% residual stenosis and absence of thrombosis.On (b)(6) 2017, the event was considered recovered/resolved.On (b)(6) 2017, the subject was discharged.On (b)(6) 2017, the subject had recurrent cramps in the left calf, which did not subside with resting or continued walking.The pain was similar to the symptoms of the previous occlusion.The subject also had the symptoms in the right foot, however, of lesser intensity.Examination of the lower left extremity revealed reduced sensory perception on dorsum of left foot (in comparison to the right foot).Colder toes on left, compared to the right.Posterior tibial artery was not palpable.Computerized tomography (ct) angiography revealed occluded left sfa, from a few centimeters after the orgio and the study stent.Other arteries, including unknown stent in common iliac artery, were patent.Recurrent occlusion of the left sfa and study stent was noted, and the subject was hospitalized for further evaluation.Left femoropopliteal bypass was recommended on a later date.On (b)(6) 2017, the subject was hospitalized for planned bypass surgery.On (b)(6) 2012, reversed venous left femoropopliteal bypass was performed.On (b)(6) 2017, the event was considered to be recovered/ resolved.On (b)(6) 2017, the subject was discharged.

• 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: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11036960
• MDR Text Key: 222319294
• Report Number: 2134265-2020-18120
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020621752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR