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

Model Number 1973-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Numbness (2415); Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier : (b)(6).

Event Description

Elegance study.It was reported that a target vessel occlusion occurred.The subject underwent treatment with the ranger drug-coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right common iliac artery with 5.00 mm proximal reference vessel diameter and 5.00 mm distal reference vessel diameter.The lesion length was 40 mm with 40 percent stenosis, and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, pre-dilatation was performed using 6.0 mm x 60 mm charger pta balloon.The treatment of target lesion was performed by dilatation using study device 6 mm x 60 mm, ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 10 percent.On the same day, the subject was discharged on aspirin.On (b)(6) 2022, the subject was noted with acute lower extremity pain and numbness.Of note, subject had undergone bilateral femoral to femoral bypass surgery a day before on (b)(6) 2022.Physical examination revealed 2+ femoral pulses, 0 dorsalis pedis pulses and 0 posterior tibial pulses on the right and left limb, however, there were no areas of ulceration, gangrene or signs of microembolization.Subsequently, duplex scan was performed on bilateral leg revealed bilateral femoral to femoral bypass graft velocities less than 40 cm/sec suggestive of impending graft failure and occlusion of right proximal to distal external iliac artery.Based on the above findings subject was hospitalized on the same day for pain control and iv heparin was started and aorto-bifemoral bypass surgery was planned on next day.On (b)(6) 2022, 13 days post-index procedure, thrombotic occlusion noted in the right external iliac artery and common femoral arteries were treated by thrombectomy and with aorto-femoral bypass graft surgery on the right leg (target limb) using 12 mm x 7 mm hemaguard bifurcated graft.In addition, thrombotic occlusion noted in the left external iliac artery, common femoral and profundal arteries were treated by thrombectomy and with aorto-femoral bypass graft surgery on the left leg (non-target limb) using the same 12 mm x 7 mm hemaguard bifurcated graft.Post procedure, subject has biphasic doppler signals in the bilateral dorsal pedal and posterior tibial arteries.Non-target lesions were treated during the aorto-bifemoral bypass graft procedure as thrombotic occlusion was noted only in the right common femoral and external iliac arteries only.On (b)(6) 2022, the event was considered to be resolved.And on (b)(6) 2022, the subject was discharged from the hospital.

Manufacturer Narrative

Patient identifier a1: (b)(6).

Event Description

Elegance study it was reported that a target vessel occlusion occurred.The subject underwent treatment with the ranger drug-coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right common iliac artery with 5.00 mm proximal reference vessel diameter and 5.00 mm distal reference vessel diameter.The lesion length was 40 mm with 40 percent stenosis, and was classified as tasc ii b lesion.Prior to target lesion treatment with study device, pre-dilatation was performed using 6.0 mm x 60 mm charger pta balloon.The treatment of target lesion was performed by dilatation using study device 6 mm x 60 mm, ranger drug coated balloon.Post treatment, the final residual stenosis was noted to be 10 percent.On the same day, the subject was discharged on aspirin.On (b)(6) 2022, the subject was noted with acute lower extremity pain and numbness.Of note, subject had undergone bilateral femoral to femoral bypass surgery a day before on (b)(6) 2022.Physical examination revealed 2+ femoral pulses, 0 dorsalis pedis pulses and 0 posterior tibial pulses on the right and left limb, however, there were no areas of ulceration, gangrene or signs of microembolization.Subsequently, duplex scan was performed on bilateral leg revealed bilateral femoral to femoral bypass graft velocities less than 40 cm/sec suggestive of impending graft failure and occlusion of right proximal to distal external iliac artery.Based on the above findings subject was hospitalized on the same day for pain control and iv heparin was started and aorto-bifemoral bypass surgery was planned on next day.On (b)(6) 2022, 13 days post-index procedure, thrombotic occlusion noted in the right external iliac artery and common femoral arteries were treated by thrombectomy and with aorto-femoral bypass graft surgery on the right leg (target limb) using 12 mm x 7 mm hemaguard bifurcated graft.In addition, thrombotic occlusion noted in the left external iliac artery, common femoral and profundal arteries were treated by thrombectomy and with aorto-femoral bypass graft surgery on the left leg (non-target limb) using the same 12 mm x 7 mm hemaguard bifurcated graft.Post procedure, subject has biphasic doppler signals in the bilateral dorsal pedal and posterior tibial arteries.Non-target lesions were treated during the aorto-bifemoral bypass graft procedure as thrombotic occlusion was noted only in the right common femoral and external iliac arteries only.On (b)(6) 2022, the event was considered to be resolved.And on (b)(6) 2022, the subject was discharged from the hospital.Additional information from the site confirmed that the right common iliac artery (target lesion) was not revascularized as the target lesion was patent, and aorto-bifemoral bypass graft was performed due to femoral to femoral graft failure and occlusion of right proximal to distal external iliac arteries.

• Brand Name: RANGER PACLITAXEL-COATED PTA BALLOON CATHETER
• Type of Device: DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): HEMOTEQ AG; adenauerstrasse 15; wuerselen 52146 ; GM 52146
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15225171
• MDR Text Key: 297889349
• Report Number: 2134265-2022-08385
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976103
• UDI-Public: 08714729976103
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P190019
• 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,Followup
• Report Date: 10/04/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 00511H22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/28/2022
• Initial Date FDA Received: 08/15/2022
• Supplement Dates Manufacturer Received: 09/13/2022
• Supplement Dates FDA Received: 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Race: Black Or African American