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 01/04/2024

Event Type  Injury  

Manufacturer Narrative

A1- patient identifier:(b)(6).

Event Description

Elegance clinical trial.It was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloons on (b)(6) 2024 as a part of the elegance clinical trial.The target lesion #001 was in the right mid superficial femoral artery extending up to right distal superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with 180 mm lesion length with 80 % stenosis and was classified as tasc ii b lesion.Prior to the treatment of target lesion with study devices, atherectomy was performed using a non-boston scientific (bsc) atherectomy device, lithotripsy was performed using 6 mm x 60 mm non-bsc lithotripsy device, and pre-dilation was performed using 6 mm x 100 mm non-bsc scoring balloon and 6 mm x 150 mm sterling pta balloon.Treatment of target lesion was performed by dilation using 6 mm x 200 mm and 6 mm x 60 mm ranger drug coated balloons, study device.Post treatment was performed by placement of non-bsc endovascular system bare metal stent.Post procedure, the final residual stenosis was noted to be 0%.On (b)(6) 2024, on the same day of index procedure, during the treatment of target lesion #001, dissection of grade c was noted due to 6 mm x 150 mm sterling pta balloon.Per edc, in response to the complication, bailout stent was placed.Post treatment, the final residual stenosis was noted to be 0%.On the same day, the complication of dissection was considered resolved and the subject was discharged from hospital on aspirin and clopidogrel.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18769137
• MDR Text Key: 336126069
• Report Number: 2124215-2024-05666
• 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: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2024
• 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: 01/30/2024
• 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 Age: 76 YR
• Patient Sex: Female
• Patient Ethnicity: Hispanic