MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Sterling?; catheter, percutaneous

Model Number	H74939032502210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that dissection occurred, requiring additional intervention.On (b)(6) 2026, the subject underwent treatment with the eluvia drug-eluting stent as part of the clinical trial.The target lesion #001 was located in the right mid superficial femoral artery, with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, a lesion length of 290 mm, and 95% stenosis, and was classified as a trans-atlantic inter-society consensus (tasc ii) c lesion.Prior to treatment with the study devices, pre-dilation was performed using a 5 mm x 220 mm sterling otw pta balloon.Treatment of the target lesion was performed using 6 mm x 150 mm and 6 mm x 120 mm eluvia drug-eluting stents, followed by dilation with a 5 mm x 40 mm ranger drug-coated balloon.Following treatment, post-dilation was performed using a 6 mm x 150 mm sterling otw pta balloon, and the final residual stenosis was noted to be 0%.On (b)(6) 2026, during treatment of the target lesion, a grade d dissection was noted in the right mid superficial femoral artery.The site confirmed that the 5 mm x 220 mm sterling otw pta balloon was associated with the dissection.In response to the event, a bailout stent was placed, and the final residual stenosis was 0%.The dissection was considered resolved on (b)(6) 2026, and the subject was discharged from the hospital on the same day on dual antiplatelet therapy.
Additional Manufacturer Narrative
Detailed product information was not provided to bsc.We completed a good faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other specific product information.If additional details become available, a supplemental report will be submitted.

• Brand Name: Sterling?
• Common Device Name: catheter, percutaneous
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): Boston Scientific Corporation; two scimed place; maple grove MN 55311
• Manufacturer Contact: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; +1(612)875-7234
• MDR Report Key: 50673764
• Report Number: 2124215-2026-47875
• Device Sequence Number: 15837843
• Product Code: LIT
• UDI-Device Identifier: 08714729845409
• UDI-Public: (01)08714729845409(17)290113(10)38349683
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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
• Operator of Device: Health Professional
• Device Model Number: H74939032502210
• Device Catalogue Number: H74939032502210
• Device Lot Number: 0038349683
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2026
• Supplement Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/08/2026
• Supplement Report FDA Received Date: 10/01/2026
• Date Device Manufactured: 01/14/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male