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 08/22/2017

Event Type  Injury  

Event Description

The patient was enrolled in (b)(6) clinical study with the patient identifier of (b)(6).It was reported that in-stent stenosis of right mid superficial femoral artery (sfa) occurred.Procedure summary: as part of (b)(6) clinical study, the patient underwent treatment with the eluvia stent on (b)(6) 2016.The target lesion was located in right leg mid sfa with 90% stenosis and was 120 mm long with a proximal reference vessel diameter of 6.00 mm and distal vessel diameter of 6.00 mm and was classified as tasc ii b lesion.Target lesion was treated with pre-dilatation and placement of a 6x150 mm,130 cm eluvia drug-eluting vascular stent system.Following post-dilatation, residual stenosis was 0 percent.280 days post index procedure, patient visited the hospital for 12 month follow up visit.Duplex ultra sound core lab finding noted in-stent stenosis category as 50-99% in the target lesion.On (b)(6) 2018, during the 24 months follow up, duplex ultrasound core lab finding noted a in-stent stenosis category as 50-99% in the target lesion.No further patient complications were reported.

• 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: 8129411
• MDR Text Key: 129208686
• Report Number: 2134265-2018-63441
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• 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: 18822229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other
• Patient Age: 79 YR