MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24620

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.Target lesion one was located in the right distal superficial femoral artery (sfa) extending to proximal popliteal artery with 98 % stenosis and was 92 mm long with a proximal reference vessel diameter of 5 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.Target lesion one was treated with pre-dilatation and placement of a 6 mm x 120 mm study stent.Following post-dilatation, residual stenosis was 0 %.On october 19, 2016, the subject was discharged on aspirin.On (b)(6) 2019, 1093 days post index procedure, the subject presented to hospital and diagnostics were performed which revealed occlusion in middle-stent located in the right femoral artery.This was classified as stent thrombosis.The event was considered not resolved/not recovered.

Manufacturer Narrative

E1: initial reporter phone: (b)(6).

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the imperial study on october 18, 2016 and the index procedure was performed on the same day.Target lesion one was located in the right distal superficial femoral artery (sfa) extending to proximal popliteal artery with 98 % stenosis and was 92 mm long with a proximal reference vessel diameter of 5 mm and distal vessel diameter of 5 mm and was classified as tasc ii a lesion.Target lesion one was treated with pre-dilatation and placement of a 6 mm x 120 mm study stent.Following post-dilatation, residual stenosis was 0 %.On (b)(6)2016 , the subject was discharged on aspirin.On (b)(6)2019 , 1093 days post index procedure, the subject presented to hospital and diagnostics were performed which revealed occlusion in middle-stent located in the right femoral artery.This was classified as stent thrombosis.The event was considered not resolved/not recovered.It was further reported that core lab findings dated (b)(6)2016 , radial stent deformation was noted.No stent fracture was noted.

• 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
• MDR Report Key: 9297945
• MDR Text Key: 165659334
• Report Number: 2134265-2019-13521
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/10/2020

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: 0018765495
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 11/08/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 70 YR