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 11/13/2018

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that in-stent restenosis occurred.The patient was enrolled in the imperial clinical study on (b)(6) 2017, and the index procedure was performed on the same day.The target lesion was located in the left distal superficial femoral artery (sfa).The target lesion was 90% stenosed, was 100mm long with a proximal and distal reference vessel diameter of 6mm, and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and a 6x120mm eluvia stent was placed.Residual stenosis was 0%.On (b)(6) 2018, the patient presented to the hospital for further treatment.On (b)(6) 2018, an angiography of the left leg revealed 75% stenosis in the mid portion of the left sfa extending to the proximal popliteal artery, including the study stent located in the distal portion.Additional intervention was performed and residual stenosis was 0%.

• 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: 8156750
• MDR Text Key: 130167642
• Report Number: 2134265-2018-63941
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 18348104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2018
• 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: 64 YR