MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COYOTE; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24704
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A1: patient identifier:(b)(6).
Event or Problem Description
Elegance clinical study it was reported that vessel dissection occurred.In (b)(6) 2023, the subject underwent treatment with ranger drug coated balloon and eluvia drug-eluting stent as a part of the elegance clinical trial.The target lesion #001 was in the right mid popliteal artery extending into right distal popliteal artery with proximal reference vessel diameter of 4 mm and distal reference vessel diameter of 4 mm with lesion length of 60 mm and 75% stenosis and was classified as tasc ii d lesion.Treatment of target lesion was performed by dilation using study device, 4 mm x 60 mm of ranger drug-coated balloon.Post treatment, the final residual stenosis was noted to be 30%.The target lesion #002 was in the right distal superficial femoral artery with proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm with lesion length of 15 mm and 80% stenosis and was classified as tasc ii d lesion.Treatment of target lesion was performed by placement of study device, 6 mm x 40 mm eluvia drug-eluting stent.Following post-dilation was performed with 6 mm x 40 mm mustang pta balloon and 4 mm x 40 mm advance pta balloon and the final residual stenosis was noted to be 0%.On the same day of index procedure, non-flow limiting dissection of grade b was noted within the tp trunk into the right posterior tibial artery due to 2.5 mm x 80 mm coyote otw pta balloon.Dissection noted was treated using a 3 mmx 12 mm non-boston scientific (bsc) balloon with improvement in the flow.Two days later, the subject was discharged on aspirin and clopidogrel.No additional information is available from site at this point of time.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 17038799
• Report Number: 2124215-2023-25135
• Device Sequence Number: 6515904
• Product Code: DQY
• UDI-Device Identifier: 08714729797180
• UDI-Public: 08714729797180
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K111295
• 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
• Report Date (Section B): 06/01/2023

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: 09/22/2025
• Device Model Number: 24704
• Device Catalogue Number: 24704
• Device Lot Number: 0030203614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2022
• 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: 81 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic