MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RANGER PACLITAXEL-COATED PTA BALLOON CATHETER; DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER

Model Number	1973-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical study.It was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.8 mm proximal reference vessel diameter and 6.7 mm distal reference vessel diameter with lesion length 300 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed by using 5 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by using study device of sizes, 6 mmx 200 mm and 6 mm x 100 mm ranger drug coated balloons and two 7 mm x 120 mm eluvia drug coated stents.Following post-dilation was performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 400 mm non-bsc balloon, the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001 dissection of grade d was noted.The final residual stenosis was noted to be 0%.The dissection was caused due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons.In response to the complication, a bailout stent was placed.On the same day, the complication was resolved, and the subject was discharged on aspirin and clopidogrel.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: 51 years old at time of enrollment.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: 51 years old at time of enrollment.
Event or Problem Description
Elegance clinical study it was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.8 mm proximal reference vessel diameter and 6.7 mm distal reference vessel diameter with lesion length 300 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed by using 5 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by using study device of sizes, 6 mmx 200 mm and 6 mm x 100 mm ranger drug coated balloons and two 7 mm x 120 mm eluvia drug coated stents.Following post-dilation was performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 400 mm non-bsc balloon, the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of target lesion #001 dissection of grade d was noted.The final residual stenosis was noted to be 0%.The dissection was caused due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons.In response to the complication, a bailout stent was placed.On the same day, the complication was resolved, and the subject was discharged on aspirin and clopidogrel.It was further reported that on (b)(6) 2023 during the treatment of target lesion #001 dissection of grade d was noted due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons which was treated by placement of three 7 mm x 120 mm eluvia stents.Post dilation of stents were performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 40 mm non-bsc pta balloon.
Additional Manufacturer Narrative
A1 - patient identifier: (b)(6).A2 - age at time of event: 51 years old at time of enrollment.
Event or Problem Description
Elegance clinical study.It was reported that a dissection occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on 03-oct-2023 as a part of the elegance clinical trial.The target lesion #001 was in the right proximal superficial artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 6.8 mm proximal reference vessel diameter and 6.7 mm distal reference vessel diameter with lesion length 300 mm with 100% stenosis and was classified as tasc ii d lesion.Prior to the treatment of target lesion with the study device, pre-dilation was performed by using 5 mm x 220 mm sterling pta balloon.Treatment of target lesion was performed by using study device of sizes, 6 mmx 200 mm and 6 mm x 100 mm ranger drug coated balloons and two 7 mm x 120 mm eluvia drug coated stents.Following post-dilation was performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 400 mm non-bsc balloon, the final residual stenosis was noted to be 0%.On 03-oct-2023, on the same day of index procedure, during the treatment of target lesion #001 dissection of grade d was noted.The final residual stenosis was noted to be 0%.The dissection was caused due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons.In response to the complication, a bailout stent was placed.On the same day, the complication was resolved, and the subject was discharged on aspirin and clopidogrel.It was further reported that on 03-oct-2023 during the treatment of target lesion #001 dissection of grade d was noted due to 6 mm x 200 mm and 6 mm x 100 mm ranger drug coated balloons which was treated by placement of three 7 mm x 120 mm eluvia stents.Post dilation of stents were performed using 6 mm x 200 mm sterling pta balloon and 6 mm x 40 mm non-bsc pta balloon.It was further reported that the target lesion #001 was in the right ostial superficial femoral artery, right proximal superficial femoral artery, right mid superficial femoral artery extending up to right distal superficial femoral artery.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Common Device Name: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18102654
• Report Number: 2124215-2023-58431
• Device Sequence Number: 7891311
• Product Code: ONU
• UDI-Device Identifier: 08714729976141
• UDI-Public: 08714729976141
• Combination Product (Y/N): Y
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P190019
• 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,Followup
• Report Date (Section B): 04/16/2024

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: 03/21/2025
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 02716H23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: 02/26/2024; 03/26/2024
• Initial Report FDA Received Date: 11/09/2023
• Supplement Report FDA Received Date: 03/15/2024; 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Race: White