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

Model Number	24716
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).
Event or Problem Description
Elegance safety.It was reported that vessel dissection occurred.In (b)(6) 2023, the subject underwent treatment with the ranger drug coated balloons.The target lesion 1 was in the right proximal superficial femoral artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length of 220 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, pre-dilation was performed using 4 mm x 100 mm and 6 mm x 200 mm sterling pta balloons and 3 mm x 80 mm non-boston scientific balloon.Treatment of target lesion was performed by dilation using of two 6 mm x 150 mm ranger drug-coated balloons study devices.Post target lesion treatment was performed by placement of non-boston scientific stent and dilation using 6.0 mm x 150 mm sterling pta balloon.Following treatment, the final residual stenosis was noted to be 0%.Index procedure was performed on the same day.However, during treatment of target lesion 1, dissection of grade d was noted due to boston scientific (bsc) adjunctive device 6 mm x 200 mm sterling pta balloon.In response to the dissection, bailout stent was placed.Post treatment, the final residual stenosis was noted to be 0%.The complication was resolved on the same day and the subject was discharged on dual antiplatelet therapy.
Event or Problem Description
Elegance safety.It was reported that vessel dissection occurred.In (b)(6) 2023, the subject underwent treatment with the ranger drug coated balloons.The target lesion 1 was in the right proximal superficial femoral artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.0 mm proximal reference vessel diameter and 6.0 mm distal reference vessel diameter with lesion length of 220 mm and 100% stenosis and was classified as tasc ii d lesion.Prior to target lesion treatment with study device, pre-dilation was performed using 4 mm x 100 mm and 6 mm x 200 mm sterling pta balloons and 3 mm x 80 mm non-boston scientific balloon.Treatment of target lesion was performed by dilation using of two 6 mm x 150 mm ranger drug-coated balloons study devices.Post target lesion treatment was performed by placement of non-boston scientific stent and dilation using 6.0 mm x 150 mm sterling pta balloon.Following treatment, the final residual stenosis was noted to be 0%.Index procedure was performed on the same day.However, during treatment of target lesion 1, dissection of grade d was noted due to boston scientific (bsc) adjunctive device 6 mm x 200 mm sterling pta balloon.In response to the dissection, bailout stent was placed.Post treatment, the final residual stenosis was noted to be 0%.The complication was resolved on the same day and the subject was discharged on dual antiplatelet therapy.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).D4 updated: 1.Model number/catalog number.2.Lot number from unknown to 0031728228.3.Expiration date from unknown to 05/30/2026.4.Unique identifier (udi) #.H4 device manufacture date updated.G4 premarket / 510(k) # updated.

• 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 SCIMED, INC; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17461965
• Report Number: 2124215-2023-38349
• Device Sequence Number: 2904889
• Product Code: LIT
• UDI-Device Identifier: 08714729845478
• UDI-Public: 08714729845478
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K132430
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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 Expiration Date: 05/30/2026
• Device Model Number: 24716
• Device Catalogue Number: 24716
• Device Lot Number: 0031728228
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 09/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2023
• 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: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic