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 Reocclusion (1985); Numbness (2415); Claudication (2550)

Event Date 08/24/2017

Event Type  Injury  

Manufacturer Narrative

Device is combination product.Initial reporter address 1: (b)(6) hospital (b)(6).

Event Description

(b)(6) clinical study.It was reported that stenosis occurred.The subject underwent treatment with one study device on (b)(6) 2017 as part of the (b)(6) clinical trial.The target lesion was located in right distal superficial femoral artery (sfa) with 100% stenosis.The lesion was 40 mm long with a proximal and distal reference vessel diameter of 5 mm and was classified as a tasc ii a lesion.The target lesion was treated with pre-dilatation and placement of the 6 mm x 60 mm stent with 0% residual stenosis.Following post dilation, residual stenosis was 0%.The subject was treated as an outpatient on dual antiplatelet therapy (dapt).On (b)(6) 2017, the subject had symptoms of increasing calf claudication of the right side and numbness of the right foot.The calf claudication occurs after a walking distance of nearly 300 m.On (b)(6) 2017, the subject presented to the hospital with a worsening calf claudication.On examination, the temperature of the lower extremities were symmetrically warm, right foot cool compared to the left side.Recapitalization was delayed on the right with quiet, low frequency flow sounds in the inguinal regions bilaterally and high frequency quiet flow sounds at the proximal thigh on the right along with not palpable upper peripheral pulses on the right.On the same day, colour coded duplex ultrasound of the right arteries revealed a long segment of the hemodynamically relevant flow acceleration in the proximal region of the superficial femoral artery with still bi- to triphasic flow signal into the region of the distal popliteal artery and the stent placed in the region of distal sfa is open and shows perfusion without stenosis.However, the superficial femoral artery showed 50-75% of long stenosis.Since the general condition of the subject worsened and to prevent a probable occlusion, a revascularization of the right proximal sfa was planned on (b)(6) 2017.During this event, the subject was on dual antiplatelet therapy.On (b)(6) 2017, the 90% stenosis was treated successfully by percutaneous transluminal angioplasty (pta) with a drug coated 6 mm x 60 mm ranger balloon with 25% residual stenosis.During the same procedure, angioplasty was performed with one 3 mm x 150 mm ranger balloon and one 2.5 mm x 150 mm ranger balloon for tibiofibularis and posterior tibial artery.On (b)(6) 2017, the event was considered resolved and was recommended to be on dual antiplatelet therapy.On (b)(6) 2017, core lab findings for distal sfa revealed non-patent inflow and outflow to the target distal sfa vessel with no thrombus or aneurysm.

• 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; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9801091
• MDR Text Key: 182792625
• Report Number: 2134265-2020-02634
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0019370764
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/14/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• 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): Required Intervention
• Patient Age: 69 YR