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 09/19/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that restenosis 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 #1 was in the left mid-superficial femoral artery (sfa) with 90% stenosis and was 160 mm long with a proximal reference vessel diameter of 5 mm and distal vessel diameter of 5 mm and was classified as tasc ii b lesion.Target lesion #1 was treated with pre-dilatation and placement of 6 mm x 150 mm and 6 mm x 60 mm study stents.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin.On (b)(6) 2017, the subject was noted to have low grade stenosis in the stent and popliteal artery.In response to the event, no action was taken.At the time of reporting, the outcome of the event was considered as recovering/resolving.

Event Description

It was reported that restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.Target lesion #1 was in the left mid-superficial femoral artery (sfa) with 90% stenosis and was 160 mm long with a proximal reference vessel diameter of 5 mm and distal vessel diameter of 5 mm and was classified as tasc ii b lesion.Target lesion #1 was treated with pre-dilatation and placement of 6 mm x 150 mm and 6 mm x 60 mm study stents.Following post-dilatation, residual stenosis was 0%.On (b)(6) 2016, the subject was discharged on aspirin.On (b)(6) 2017, the subject was noted to have low grade stenosis in the stent and popliteal artery.In response to the event, no action was taken.At the time of reporting, the outcome of the event was considered as recovering/resolving.It was further reported that the outcome of the event was considered not recovered/not resolved.

Manufacturer Narrative

E1 initial reporter address 1: (b)(6).

• 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: 10749303
• MDR Text Key: 213488434
• Report Number: 2134265-2020-14850
• 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: 11/19/2020

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: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018822232
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 11/06/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR