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 Ischemia (1942); Reocclusion (1985); Injury (2348)

Event Date 07/21/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).

Event Description

(b)(6) study.It was reported that restenosis occurred.The subject underwent treatment with a study device on (b)(6) 2018 as part of the eminent clinical trial.The target lesion was located in right proximal superficial femoral artery (sfa) with 80% stenosis.The lesion was 40 mm long with a proximal reference vessel of 5 mm and a distal reference vessel diameter of 5 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of the 6 mm x 40 mm stent.Following post dilation, the residual stenosis was 0%.Dissection occurred on the segment below the stent, without arterial caliber reduction and was not extensive.The subject was treated as an outpatient.On (b)(6) 2020, the subject was hospitalized with ischemia of both lower limbs along with rectal bleeding.Diagnostic tests revealed thrombosis of the two common femoral arteries and occlusion of the two iliac arteries.The subject was referred for emergency surgical management.Angioplasty of the right iliac and angioplasty of the left external iliac was performed, but revascularization failed.The 100% stenosis in right proximal sfa was treated with percutaneous transluminal angioplasty (pta).Due to the failure of revascularization, on (b)(6) 2020, a right thigh amputation was performed.At the time of reporting, the event outcome was considered ongoing.

• 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: 10402863
• MDR Text Key: 202769627
• Report Number: 2134265-2020-11017
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020803329
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR