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 Problem Thrombosis (2100)

Event Date 10/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported the patient had recurring stent thrombosis.On (b)(6) 2018, the patient underwent treatment with the eluvia device as part of the (b)(6) clinical trial.The target lesion was located in the right ostial, proximal and mid superficial femoral artery (sfa).The lesion had 5.7mm and 4.1mm reference vessel diameter, proximally and distally respectively.The lesion had a total length of 180mm.The lesion was 100% occluded and was crossed subintimally.Pre-dilataion was performed using five balloons and two 6x120mm eluvia stents were implanted.Two additional non-bsc stents were implanted due to dissection.Post-dilataion was performed using three balloons.Residual stenosis was 25%.On (b)(6) 2018, the patient experienced stent thrombosis.The patient was hospitalized and thrombolysis with alteplase was performed.The patient was discharged on (b)(6) 2018 and the event was assessed as resolved the same day.On (b)(6) 2018, the patient experienced stent thrombosis.The patient was hospitalized and thrombosuction was performed and a stent was placed.The patient was discharged on (b)(6) 2018 "an" the event was assessed as resolved the same day.On (b)(6) 2018, the patient experienced stent thrombosis.The patient was hospitalized and thrombolysis with alteplase was performed.The patient was discharged on (b)(6) 2018 and the event was assessed as resolved as of (b)(6) 2018.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8120027
• MDR Text Key: 128899655
• Report Number: 2134265-2018-63342
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021630715
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR