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 11/15/2018

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6) years old at time of enrollment.Device is a combination product.

Event Description

Imperial study : it was reported that restenosis occurred.The patient was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was located in the left proximal superficial femoral artery (sfa) extending to the left mid sfa with 90% stenosis and was 100 mm long with a proximal reference vessel diameter of 5.5 mm and distal reference diameter of 5.5 and was classified as tasc ii b lesion.The lesion was treated with pre-dilation and placement of a 6.00mm x 120 mm study stent.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the patient was discharged with dapt.On (b)(6) 2018, during the 24 month follow up, dus was performed and revealed occlusion of the study stent implanted during the index procedure in the left sfa.

• 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: 8142717
• MDR Text Key: 129633082
• Report Number: 2134265-2018-63663
• 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: 12/07/2018

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: 12/31/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18765494
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/28/2018
• Initial Date FDA Received: 12/07/2018
• 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