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

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Restenosis (4576)

Event Date 10/14/2019

Event Type  Injury  

Manufacturer Narrative

Age at time of event: (b)(6) at time of study enrollment.Initial reporter facility name: (b)(6).

Event Description

It was reported that in-stent restenosis occurred.The subject was enrolled into the (b)(6) 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) with 80% stenosis.The target lesion was 60 mm long with a proximal reference vessel diameter of 5.5 mm and a distal reference vessel diameter of 5.5 mm.It was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation using a balloon, followed by placement of a 6 mm x 60 mm study stent.Following post dilation, the residual stenosis was 0%.On (b)(6) 2017, the subject was discharged with antiplatelet therapy.On (b)(6) 2019, 830 days post index procedure, the subject presented due to progression of the disease leading to restenosis of the distal femoral artery on the left side.No action was taken at the time of diagnosis.The subject was recommended to undergo surgical intervention as a treatment for this event on later date.On (b)(6) 2020, the subject was hospitalized for planned intervention.Subject reported the onset of pain in the left lower limb at distances of approximately 200 meters.The subject was diagnosed with stage iib peripheral artery disease (pad) of the left lower limb.On the same day, ultrasound reveled patency at the common femoral and iliac levels.On the left, the superficial femoral stent was patent with, immediately downstream, stenosis seemed to be tight opposite mid left popliteal artery.80% stenosis in left distal sfa with 4.5 mm reference vessel diameter and 25 mm lesion length was treated with percutaneous transluminal angioplasty and stent was implanted.Postoperative, no complication was noticed, and the final residual stenosis was 0%.On (b)(6) 2020, the event was considered to be recovered/ resolved and the subject was discharged on the same day.

• Brand Name: ELUVIA 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12233468
• MDR Text Key: 263814842
• Report Number: 2134265-2021-09495
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: FR
• 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: 07/27/2021

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: 08/22/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020396886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention