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: year 1937.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 the 6x120 study stent 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 stent was 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.

Event Description

Regal clinical study.It was reported that stent thrombosis occurred resulting in hospitalization and amputation.The patient underwent treatment with the 6x120 study stent 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 stent was 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.It was further reported that on (b)(6) 2018, during the initial procedure another 6x120mm study stent was implanted in the right mid superficial femoral artery.

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: date of birth: year 1937.Device is a combination product.

• 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
• MDR Report Key: 9214065
• MDR Text Key: 163028015
• Report Number: 2134265-2019-12693
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 0021630715
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 11/06/2019
• Supplement Dates FDA Received: 11/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: STENT: 6X120MM ELUVIA STENT
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 81 YR