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

Model Number	24705
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Embolism/Embolus (4438)
Date of Event	04/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Elegance clinical trial.It was reported that an embolism occurred.The subject underwent treatment with the ranger drug coated balloon (dcb) on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion #001 was in the right mid superficial femoral artery (sfa) extending up to the right distal sfa.The lesion had 5.0mm proximal reference vessel diameter and 5.0mm distal reference vessel diameter with a lesion length of 200mm.The lesion was 80% stenosed and was classified as a tasc ii b lesion.Prior to target lesion treatment, treatment was performed by percutaneous transluminal angioplasty using a 4.0mm x 150mm coyote balloon.Treatment of the target lesion was performed by dilatation with a 5.0mm x 200mm ranger dcb study device.Following post dilatation, aspiration thrombectomy was performed with a non boston scientific device.The final residual stenosis was noted to be 20%.During the treatment of the target lesion #001, an embolism was noted with residual stenosis noted to be 20%.In response to the observed embolism, aspiration thrombectomy was performed.The embolism was resolved.There were no patient complications reported.
Additional Manufacturer Narrative
A1.Patient identifier added (b)(6).B2.Updated outcomes attrib to adv event.
Event or Problem Description
Elegance clinical trial: it was reported that an embolism occurred.The subject underwent treatment with the ranger drug coated balloon (dcb) on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion #001 was in the right mid superficial femoral artery (sfa) extending up to the right distal sfa.The lesion had 5.0mm proximal reference vessel diameter and 5.0mm distal reference vessel diameter with a lesion length of 200mm.The lesion was 80% stenosed and was classified as a tasc ii b lesion.Prior to target lesion treatment, treatment was performed by percutaneous transluminal angioplasty using a 4.0mm x 150mm coyote balloon.Treatment of the target lesion was performed by dilatation with a 5.0mm x 200mm ranger dcb study device.Following post dilatation, aspiration thrombectomy was performed with a non boston scientific device.The final residual stenosis was noted to be 20%.During the treatment of the target lesion #001, an embolism was noted with residual stenosis noted to be 20%.In response to the observed embolism, aspiration thrombectomy was performed.The embolism was resolved.There were no patient complications reported.It was further reported that the embolism was caused by the 4.0mm x 150mm coyote balloon and was not related to the 5.0mm x 200mm ranger study device.

• Brand Name: COYOTE
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14338629
• Report Number: 2134265-2022-05119
• Device Sequence Number: 12316660
• Product Code: DQY
• UDI-Device Identifier: 08714729796664
• UDI-Public: 08714729796664
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 06/15/2022

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: 12/14/2024
• Device Model Number: 24705
• Device Catalogue Number: 24705
• Device Lot Number: 0028560749
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/18/2022
• Supplement Date Received by Manufacturer: 05/26/2022
• Initial Report FDA Received Date: 05/09/2022
• Supplement Report FDA Received Date: 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2021
• 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; Other
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Race: Black Or African American