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 Thrombosis (2100); Ulcer (2274)

Event Date 04/27/2020

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.(b)(6).

Event Description

It was reported that thrombosis occurred.The 100% stenosed target lesion was located in non-severely calcified and moderately tortuous left superficial femoral artery (sfa).On (b)(6) 2019, a 7x80x130, 7x40x130 and two 7x120x130 eluvia self expanding stents were implanted at the target lesion.On 9 month follow-up visit, the patient was doing good.On (b)(6) 2020, one week before the 12-month follow-up schedule visit, the patient presented with severe lameness symptom and condition was not good.Echocardiogram (echo) revealed occlusion thrombosis inside the stents.It was also noted a foot ulcer.The ulcer was not on the site of eluvia placement.The patient was taking dual antiplatelet therapy (dapt) at 12 months when occlusion was found.On (b)(6) 2020, the thrombosis and foot ulcer treated by performing stent graft with non-bsc device, plain old balloon angioplasty (poba) performed in common femoral artery (cfa) and the eluvia lesion location.The ulcer was healed and severe lameness symptom was disappeared after the treatment.No further complications were reported and the patient status post procedure was fine after the retreatment.

• 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 SCIMED, INC; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10252354
• MDR Text Key: 198160428
• Report Number: 2134265-2020-09057
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023093799
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/18/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2018
• 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
• Treatment: BEASTOR BSJINFLATION DEVICE; DESTINATION 6FR, 45CMINTRODUCER SHEATH; GLADIUS GUIDEWIRE 0.014INCH, 200CM; GORE VIABAHN - (STENT GRAFT); PROMINENT 2.6FR, 150CM MICROCATHETER; SHIDEN HP 6.0-150MMBALLOON CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR