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); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 02/16/2021

Event Type  Injury  

Event Description

(b)(6) clinical study.It was reported that a restenosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed the same day.The target lesion was located in the right mid superficial femoral artery (sfa), with 100% stenosis and was 145mm long.The lesion had a proximal reference vessel diameter of 5.0mm, a distal reference vessel diameter of 5.0mm, and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of a 6.0mm x 150mm eluvia drug-eluting vascular stent.Following post-dilatation, the residual stenosis was 5%.On (b)(6) 2016, the subject was discharged on dual antiplatelet therapy.On (b)(6) 2021, the subject visited the hospital with the complaint of symptoms related to claudication.The subject reported that she was able to walk only 10-15 minutes before developing symptoms of claudication and calf pain.Angiography of the lower extremity was performed, which revealed 100% occluded right mid and distal sfa and 70% right popliteal diffuse disease.On the same day, occlusion noted in the right mid sfa, distal sfa and stenosis of popliteal artery was treated by performing atherectomy followed by placement of a drug eluting stent.The residual stenosis following the procedure is unknown.Post revascularization treatment, the subject was able to walk for 30 minutes without any treatment.The event is considered resolved.

• 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: 13776554
• MDR Text Key: 287910591
• Report Number: 2134265-2022-02782
• 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: 03/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2022
• 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: 0018822231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Hospitalization
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Race: White