MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION STERLING; CATHETER, PERCUTANEOUS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

A1 patient identifier: (b)(6).A2 age at time of event: 74 years old at the time of enrollment.

Event Description

Elegance clinical trial: the subject underwent treatment with the ranger paclitaxel-coated pta balloon catheter and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion #001 was in the left external iliac artery (eia) with 6mm proximal reference vessel diameter and 6.5mm distal reference vessel diameter with lesion length 60mm with 70% stenosis and was classified as tasc ii a lesion.Treatment of target lesion was performed by dilation using 7mm x 60mm ranger paclitaxel-coated pta balloon study device.Following post-treatment was performed by placement of 9mm x 60mm epic vascular self-expanding stent and the final residual stenosis was noted to be 30%.The target lesion #002 was in the left proximal superficial femoral artery (sfa), left mid sfa extending up to left distal sfa with 5.5mm proximal reference vessel diameter and 5mm distal reference vessel diameter with lesion length 230mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the target lesion treatment with the study device, pre-dilation was performed using 4mm x 220mm sterling over-the-wire pta balloon.Treatment of target lesion was performed by placement of two 6mm x 120mm eluvia drug-eluting stents study devices.Following post-dilation was performed using 5mm x 120mm sterling over-the-wire pta balloon and the final residual stenosis was noted to be 30%.The target lesion #003 was in the left distal sfa, left proximal popliteal artery extending up to left mid popliteal artery with 5mm proximal reference vessel diameter and 5 mm distal reference vessel diameter with lesion length 120 mm with 70% stenosis and was classified as tasc ii d lesion.Treatment of target lesion was performed by dilation using study device, 5mm x 150mm ranger paclitaxel-coated pta balloon.Following treatment, the final residual stenosis was noted to be 30%.On (b)(6) 2023, on the same day of index procedure, post pre-dilation of target lesion #002, complication of dissection was noted in the left proximal sfa and mid sfa due to 4mm x 220mm sterling pta balloon.In response to the complication, bailout stent was placed, and balloon dilation was performed.Post treatment, the final residual stenosis was noted to be 30%.On the same day, the complication of dissection was considered to be resolved.On (b)(6) 2023, the subject was discharged from the hospital on dual antiplatelet therapy.

• Brand Name: STERLING
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18898903
• MDR Text Key: 337600116
• Report Number: 2124215-2024-14294
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Sex: Female
• Patient Race: Black Or African American