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 Reocclusion (1985); Discomfort (2330)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

The patient was enrolled in (b)(6) study.It was reported that in-stent restenosis occurred.On (b)(6) 2016, the index procedure was performed.The target lesion was located in the right distal superficial femoral artery (sfa) extending to the proximal popliteal artery.The target lesion was 80% stenosed and was 40mm long with a proximal reference vessel diameter of 6.00mm and a distal vessel diameter of 6.00mm, and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation and a 7mm x 60mm eluvia stent was placed.The lesion was then post-dilated and residual stenosis was 0%.On (b)(6) 2018, the patient experienced sudden onset of right calf discomfort.On (b)(6) 2018, the patient presented to the hospital, stating the symptoms occurred while walking short distances indoors, and was relieved by rest.An ultrasound was performed which revealed in-stent restenosis (isr) of the eluvia stent.On (b)(6) 2018, the patient presented to the hospital again for intervention.Angiography confirmed the in-stent restenosis, showing that the distal sfa was 100% stenosed and the proximal popliteal artery had 100% isr.The isr was treated using laser atherectomy and balloon angioplasty with two non-bsc balloons.The lesion in the distal sfa was further treated by implantation of a non-bsc drug coated stent.The proximal right sfa was treated with drug coated balloon angioplasty.Post procedure, the angiographic results were excellent.

• 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 SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7951939
• MDR Text Key: 123246925
• Report Number: 2134265-2018-61762
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2018

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: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18334951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2018
• Initial Date FDA Received: 10/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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): Required Intervention
• Patient Age: 72 YR