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 Problem Reocclusion (1985)

Event Date 09/20/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: patient was (b)(6) years old at time of enrollment on (b)(6) 2016.

Event Description

It was reported that the patient had restenosis.The patient was enrolled in the (b)(6) study on (b)(6) 2016, and the index procedure was performed on the same day.The lesion was located in the right leg mid superficial femoral artery (sfa) with 90% stenosis and was 130 mm long with a proximal reference vessel diameter of 6.00 mm and distal vessel diameter of 6.00mm and was classified as tasc ii b lesion.The lesion was treated with pre-dilatation and a placement of a 7.0 x 150mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2018, the patient was noted with claudication, a new lesion in the proximal sfa, not related to the stented site.On (b)(6) 2018, the patient was hospitalized for further evaluation and possible treatment.In the proximal right sfa, 90% stenosis was located and treated with drug coated balloon angioplasty with 25% residual stenosis.On (b)(6) 2018, the event was considered resolved and the patient was discharged on the same day.

• 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: 8108789
• MDR Text Key: 128560806
• Report Number: 2134265-2018-63245
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18349150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention