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 Occlusion (1984)

Event Date 10/24/2019

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Date of birth: (b)(6).

Event Description

It was reported that the stent became occluded.The patient underwent treatment with the eluvia stents on (b)(6) 2017 as part of the (b)(6) clinical trial.The target lesion, located in the middle superficial femoral artery (sfa) of the right leg had a 6mm reference vessel diameter proximally and distally, and a total length of 80mm visually estimated.The target lesion was 100% occluded and crossed through true lumen.Pre-dilatation was performed using one balloon, afterwards two 6x100mm eluvia stents were implanted.Post-dilatation was performed using one balloon, and 30% residual stenosis remained.No thrombus was seen at the end of procedure.On (b)(6) 2019 total occlusion of the implanted study stents in the left sfa was observed.The patient was hospitalized on (b)(6) 2019 and a rotarex thrombectomy as well as lysis therapy was applied.The next day, an angiography with atherectomy and drug coated balloon treatment of the target lesion was performed.The patient was discharged on (b)(6) 2019 and the event was resolved.

• 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: 9305530
• MDR Text Key: 166046557
• Report Number: 2134265-2019-13572
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022992323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR