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 Obstruction/Occlusion (2422)

Event Date 07/28/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility name: (b)(6).

Event Description

Eminent clinical study.It was reported there was in-stent re-occlusion.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) involving proximal popliteal artery with 100% stenosis and was 140 mm long with a proximal reference vessel diameter of 5.0 mm and distal reference vessel diameter of 5.0 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by 6 mm x 120 mm and 6 mm x 60 mm study stents were placed.Post dilatation was performed with final residual stenosis of 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 1093 days post index procedure, the subject presented for protocol scheduled 36 months follow up visit, and complained of severe pain, aching and cramps in the right leg, unable to walk 274.32 meters, having much difficulty climbing the stairs and slight problem in doing daily activities.On arrival, rutherford category was 3 (severe claudication).Ankle brachial index performed showed 0.4.On the same day, duplex ultrasound examination performed revealed instent-occlusion of sfa in the right side.Based on the symptoms and diagnostic findings, the subject was diagnosed with instent re-occlusion of sfa and apop in the right side of the leg.No action was taken to treat the event.At the time of reporting the event was ongoing.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15437808
• MDR Text Key: 300042049
• Report Number: 2124215-2022-36099
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023259439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Race: White