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); Claudication (2550)

Event Date 01/22/2019

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 (b)(6) clinical study on (b)(6) 2016, and the index procedure was performed on the same day.The target lesion was located in the right proximal superficial femoral artery (sfa) extending to the distal sfa.The target lesion was 70% stenosed, 90mm long, and had a proximal and distal reference vessel diameter of 6mm, and was classified as a tasc ii c lesion.The lesion was treated with pre-dilatation and a 6x120mm eluvia stent was placed.Following post-dilatation, the residual stenosis was 10%.On (b)(6) 2018, the patient visited the hospital for a 24month follow up.Duplex ultra sound was performed which revealed an occluded study stent.Clinical assessment on the same day revealed one mild claudication.On (b)(6) 2019, the patient presented with claudication in the right and left lower extremities, and was hospitalized on the same day.Angiography revealed 100% occlusion in the right sfa, from the proximal portion down to the reconstitution at the end of the eluvia stent.The length was 20cm.The stenosis was treated with laser atherectomy with 1.4mm laser throughout the segment, followed by balloon angioplasty using a 4mm angiosculpt balloon, then followed by 5mm drug coated balloon therapy.On the same day, angioplasty was performed for the left leg claudication.Follow-up core-lab angiography finding dated (b)(6) 2019, noted thrombus of grade 0 and absence of aneurysm.However, core lab noted the presence of isr pattern 4.The event is considered to be resolving and the patient is recovering at the time of reporting.

• 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: 8469865
• MDR Text Key: 140493950
• Report Number: 2134265-2019-03230
• 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: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2019
• 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: 0018765488
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2016
• 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: 71 YR