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 09/23/2022

Event Type  Injury  

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: 61 years old at the time of enrollment.

Event Description

Elegance clinical trial: it was reported that vessel dissection occurred.The subject underwent treatment with the sterling balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial femoral artery, right mid superficial femoral artery extending into right distal superficial femoral artery with 6 mm proximal reference vessel diameter and 6 mm distal reference vessel diameter with lesion length of 280 mm and 30% stenosis and was classified as transatlantic intersociety consensus (tasc) ii c lesion.Prior to target lesion treatment, the pre-treatment dilation was performed using 5 mm x 150 sterling pta balloon.Treatment of target lesion was performed by using 6 mmx 200 mm ranger drug coated balloon and implanting 6 mm x 120 mm and 6 mm x 80 mm eluvia drug eluting stents.Post treatment, 6 mm x 200 mm ranger drug coated balloon was used for post dilation and the final residual stenosis was noted to be 10%.On (b)(6) 2022, on the same day of index procedure, during the treatment of target lesion #001, dissection of grade c was noted.It was confirmed that dissection was due to 5 mm x 150 mm sterling pta balloon.In response to the event, bailout stent was placed.Post treatment, the final residual stenosis the target lesions were noted to be 10%.On the same day, the event was considered resolved and the subject was discharged 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 SCIMED, INC; two scimed place; maple grove
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18879381
• MDR Text Key: 337404308
• Report Number: 2124215-2024-11295
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• 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: 02/14/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White