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); Injury (2348)

Event Date 08/24/2018

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Date of birth: (b)(6).Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that stent thrombosis occurred resulting in hospitalization and amputation.The patient underwent treatment with two 6x120 study stents on (b)(6) 2018.The target lesion, located in the right mid superficial femoral artery with a 5.8 mm and 5.9 mm reference vessel diameter.The lesion's length was 80mm proximally and distally respectively.The lesion was 100% stenosed and was crossed through the true lumen.Pre-dilatation was performed using 5 balloons; subsequently the study stents were implanted.Post-dilatation was not performed; there was 10% residual stenosis.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2018, the patient was hospitalized to undergo major amputation due to stent thrombosis.The patient was discharged on (b)(6) 2018 and the event was assessed as resolved with sequelae as of 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: 9311168
• MDR Text Key: 166050220
• Report Number: 2134265-2019-13719
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• 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: 0020890480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2017
• 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: STENT: 6X120MM ELUVIA STENT
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 81 YR