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 Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)

Event Date 05/01/2018

Event Type  Injury  

Event Description

It was reported that the stent occluded.The patient underwent treatment with the eluvia device on (b)(6) 2017 as part of the (b)(6) trial.The following lesion was treated in the left limb: proximal, middle, and distal superficial femoral artery (sfa) with 220mm length and 100% stenosis.Reference vessel diameters were 6mm proximally and 5mm distally.Pre-dilatation was performed using one balloon and the lesion was crossed through the true lumen.Three eluvia stents (6x100mm; 6x80mm; 6x80mm) were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, target vessel occlusion was discovered.Patient was hospitalized on (b)(6) 2018 for percutaneous transluminal angioplasty (pta), drug-eluting balloons (deb), and stenting.Patient was discharged on (b)(6) 2018.The event is reported as resolved as of (b)(6) 2018.

Manufacturer Narrative

Date of birth: (b)(6).Initial reporter facility name: (b)(6).

Manufacturer Narrative

H6: patient codes updated.A2: date of birth: 1943.E1: initial reporter facility name: (b)(6).

Event Description

It was reported that the stent occluded.The patient underwent treatment with the eluvia device on (b)(6) 2017 as part of the regal clinical trial.The following lesion was treated in the left limb: proximal, middle, and distal superficial femoral artery (sfa) with 220mm length and 100% stenosis.Reference vessel diameters were 6mm proximally and 5mm distally.Pre-dilatation was performed using one balloon and the lesion was crossed through the true lumen.Three eluvia stents (6x100mm; 6x80mm; 6x80mm) were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, target vessel occlusion was discovered.Patient was hospitalized on (b)(6)2018 for percutaneous transluminal angioplasty (pta), drug-eluting balloons (deb), and stenting.Patient was discharged on (b)(6) 2018.The event is reported as resolved as of (b)(6) 2018.It was further reported that the target vessel occlusion was discovered in the proximal area of the target lesion.It was assumed that the thrombosis involved one of the two stents used in the proximal tract of the sfa.It cannot be determined if the thrombosis involved the 80mm stent with lot number 20993693 rather than the 80mm stent with lot number 20433975.

• 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: 13804464
• MDR Text Key: 287399506
• Report Number: 2134265-2022-02950
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020330963
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male