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 Occlusion (1984); Thrombosis (2100)

Event Date 07/30/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that in-stent occlusion occurred.The patient underwent treatment with the eluvia trial device on (b)(6) 2018 as part of the regal clinical trial.The 100% stenosed target lesion was located in the right distal and proximal superficial femoral artery (sfa) that was 240 mm in length with 6 mm reference vessel diameter, proximally and distally.Pre-dilatation was performed using one balloon.Afterwards three eluvia, two 6 x 120 and one 6 x 80, stents were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019 an in-stent occlusion of the 6 x 120 eluvia stent within the right sfa was detected.The patient was hospitalized on (b)(6) 2019 and percutaneous transluminal angioplasty and thrombolysis were performed.The patient was discharged from the hospital on (b)(6) 2019 and the event was considered resolved.

Event Description

It was reported that in-stent occlusion occurred.The patient underwent treatment with the eluvia trial device on june 20, 2018 as part of the regal clinical trial.The 100% stenosed target lesion was located in the right distal and proximal superficial femoral artery (sfa) that was 240mm in length with 6mm reference vessel diameter, proximally and distally.Pre-dilatation was performed using one balloon.Afterwards three eluvia, two 6x120 and one 6x80, stents were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019 an in-stent occlusion of the 6x120 eluvia stent within the right sfa was detected.The patient was hospitalized on (b)(6) 2019 and percutaneous transluminal angioplasty and thrombolysis were performed.The patient was discharged from the hospital on (b)(6) 2019 and the event was considered resolved.Additional information further reported that the occlusion was thrombosis.The reintervention was located at the distal end of the sfa to the start of the proximal popliteal artery (ppa).Additional information further reported that all three stents were occluded.

Manufacturer Narrative

Patient identifier: (b)(4).Date of birth: 1958.

Manufacturer Narrative

Patient identifier: (b)(6).Date of birth: 1958.

Event Description

It was reported that in-stent occlusion occurred.The patient underwent treatment with the eluvia trial device on (b)(6) 2018 as part of the regal clinical trial.The 100% stenosed target lesion was located in the right distal and proximal superficial femoral artery (sfa) that was 240mm in length with 6mm reference vessel diameter, proximally and distally.Pre-dilatation was performed using one balloon.Afterwards three eluvia, two 6x120 and one 6x80, stents were implanted.Post-dilatation was performed using one balloon and residual stenosis was 0%.No thrombus was seen in the treated vessel at the end of the procedure.On (b)(6) 2019 an in-stent occlusion of the 6x120 eluvia stent within the right sfa was detected.The patient was hospitalized on (b)(6) 2019 and percutaneous transluminal angioplasty and thrombolysis were performed.The patient was discharged from the hospital on (b)(6) 2019 and the event was considered resolved.Additional information further reported that the occlusion was thrombosis.The reintervention was located at the distal end of the sfa to the start of the proximal popliteal artery (ppa).

• 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: 9179619
• MDR Text Key: 161977092
• Report Number: 2134265-2019-12290
• 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,Followup
• Report Date: 11/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2019
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0021466894
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 61 YR