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

Model Number 1177-01

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

Patient Problems Ischemia (1942); Pain (1994); Obstruction/Occlusion (2422); Vascular Dissection (3160); Paresthesia (4421); Restenosis (4576)

Event Date 12/22/2022

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.

Event Description

Elegance study it was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with ranger drug-coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right common femoral artery, right external iliac artery and right proximal superficial femoral artery (sfa).The lesion had a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, with a lesion length of 60 mm.The lesion was 50% stenosed and classified as tasc ii b.Prior to target lesion treatment with study device, pre-dilatation was performed using 6mm x 40mm mustang pta balloon.Treatment of target lesion was performed by study device, 6 mm x 80 mm ranger drug-coated balloon.Following placement of a 5mm x 40mm innova bare metal stent, the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, the subject experienced symptoms of acute limb ischemia in the right leg.On the same day, subject was admitted to the hospital.On (b)(6) 2022, 114 days post-index procedure, 100% stenosis was noted in the right external iliac artery, internal iliac artery, right proximal sfa and posterior tibial artery were treated with mechanical thrombectomy followed by catheter-directed thrombolysis.Post procedure, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the stenosis noted in lower right leg was treated with dacron interposition grafting, thrombectomy and fasciotomy.

Event Description

Elegance study it was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with ranger drug-coated balloon on 05-sep-2022 as a part of the elegance clinical trial.The target lesion was in the right common femoral artery, right external iliac artery and right proximal superficial femoral artery (sfa).The lesion had a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, with a lesion length of 60 mm.The lesion was 50% stenosed and classified as tasc ii b.Prior to target lesion treatment with study device, pre-dilatation was performed using 6mm x 40mm mustang pta balloon.Treatment of target lesion was performed by study device, 6 mm x 80 mm ranger drug-coated balloon.Following placement of a 5mm x 40mm innova bare metal stent, the final residual stenosis was noted to be 0%.On 06-sep-2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022 the subject experienced symptoms of acute limb ischemia in the right leg.On the same day, subject was admitted to the hospital.On (b)(6) 2022 114 days post-index procedure, 100% stenosis was noted in the right external iliac artery, internal iliac artery, right proximal sfa and posterior tibial artery were treated with mechanical thrombectomy followed by catheter-directed thrombolysis.Post procedure, the final residual stenosis was noted to be 20%.On (b)(6) 2022 the stenosis noted in lower right leg was treated with dacron interposition grafting, thrombectomy and fasciotomy.Updated clinical information indicated that the percentage of stenosis post-treatment on (b)(6) 2022 was in fact still 100% (not the 20% that was previously reported).Further details were given regarding treatment of the stenosis on (b)(6) 2022.The 100% stenosis noted in right proximal superficial femoral artery and external iliac artery was treated with longitudinal arteriotomy, and previously placed stent in right sfa and external iliac artery were removed followed by thrombectomy in the proximal and distal sfa which revealed good inflow and moderate backflow.Subsequently an 8mm dacron interposition grafting was performed form the external iliac artery to the superficial femoral artery.Post-procedure, angiogram reveled dissection of hunters canal and p2 segment popliteal artery following which 6 mm x 60 mm eluvia stent was placed in sfa and 5 mm x 80 mm supera stent was placed in popliteal artery.On the same day, fasciotomy of all four compartment in the lower leg was performed.Post procedure, the final residual stenosis was noted to be 0%.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.

Event Description

Elegance study it was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with ranger drug-coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right common femoral artery, right external iliac artery and right proximal superficial femoral artery (sfa).The lesion had a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, with a lesion length of 60 mm.The lesion was 50% stenosed and classified as tasc ii b.Prior to target lesion treatment with study device, pre-dilatation was performed using 6mm x 40mm mustang pta balloon.Treatment of target lesion was performed by study device, 6 mm x 80 mm ranger drug-coated balloon.Following placement of a 5mm x 40mm innova bare metal stent, the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, the subject experienced symptoms of acute limb ischemia in the right leg.On the same day, subject was admitted to the hospital.On (b)(6) 2022, 114 days post-index procedure, 100% stenosis was noted in the right external iliac artery, internal iliac artery, right proximal sfa and posterior tibial artery were treated with mechanical thrombectomy followed by catheter-directed thrombolysis.Post procedure, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the stenosis noted in lower right leg was treated with dacron interposition grafting, thrombectomy and fasciotomy.Updated clinical information indicated that the percentage of stenosis post-treatment on (b)(6) 2022 was in fact still 100% (not the 20% that was previously reported).Further details were given regarding treatment of the stenosis on (b)(6) 2022.The 100% stenosis noted in right proximal superficial femoral artery and external iliac artery was treated with longitudinal arteriotomy, and previously placed stent in right sfa and external iliac artery were removed followed by thrombectomy in the proximal and distal sfa which revealed good inflow and moderate backflow.Subsequently an 8mm dacron interposition grafting was performed form the external iliac artery to the superficial femoral artery.Post-procedure, angiogram reveled dissection of hunters canal and p2 segment popliteal artery following which 6 mm x 60 mm eluvia stent was placed in sfa and 5 mm x 80 mm supera stent was placed in popliteal artery.On the same day, fasciotomy of all four compartment in the lower leg was performed.Post procedure, the final residual stenosis was noted to be 0%.Clinical information again updated the percentage of stenosis post-treatment on (b)(6)2022 to 50% (not the 20% or 100% previously reported).

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.

Event Description

Elegance study: it was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with ranger drug-coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right common femoral artery, right external iliac artery and right proximal superficial femoral artery (sfa).The lesion had a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, with a lesion length of 60 mm.The lesion was 50% stenosed and classified as tasc ii b.Prior to target lesion treatment with study device, pre-dilatation was performed using 6mm x 40mm mustang pta balloon.Treatment of target lesion was performed by study device, 6 mm x 80 mm ranger drug-coated balloon.Following placement of a 5mm x 40mm innova bare metal stent, the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, the subject experienced symptoms of acute limb ischemia in the right leg.On the same day, subject was admitted to the hospital.On (b)(6) 2022, 114 days post-index procedure, 100% stenosis was noted in the right external iliac artery, internal iliac artery, right proximal sfa and posterior tibial artery were treated with mechanical thrombectomy followed by catheter-directed thrombolysis.Post procedure, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the stenosis noted in lower right leg was treated with dacron interposition grafting, thrombectomy and fasciotomy.Updated clinical information indicated that the percentage of stenosis post-treatment on (b)(6) 2022 was in fact still 100% (not the 20% that was previously reported).Further details were given regarding treatment of the stenosis on (b)(6) 2022.The 100% stenosis noted in right proximal superficial femoral artery and external iliac artery was treated with longitudinal arteriotomy, and previously placed stent in right sfa and external iliac artery were removed followed by thrombectomy in the proximal and distal sfa which revealed good inflow and moderate backflow.Subsequently an 8mm dacron interposition grafting was performed form the external iliac artery to the superficial femoral artery.Post-procedure, angiogram reveled dissection of hunters canal and p2 segment popliteal artery following which 6 mm x 60 mm eluvia stent was placed in sfa and 5 mm x 80 mm supera stent was placed in popliteal artery.On the same day, fasciotomy of all four compartment in the lower leg was performed.Post procedure, the final residual stenosis was noted to be 0%.Clinical information again updated the percentage of stenosis post-treatment on (b)(6) 2022 to 50% (not the 20% or 100% previously reported).Clinical information was again updated, this changed some of the information that was previously reported.The patient had started experiencing right leg pain (b)(6) 2022.On (b)(6) 2022, after being admitted to the hospital, the subject's right leg was cool when compared with the other leg with several areas of livid discoloration in the region of d1 on the right leg.Subject also reported to have tingling paresthesia.Additionally, sonography revealed inguinal pulses and pulses at more distal sites of the right side were not palpable, with only venous flow patterns being observed on the right side.A ct angiography (performed (b)(6) 2022) which revealed in-stent stenosis of the right external iliac artery, and occlusion of the right external iliac artery, right common femoral artery, and right superficial femoral artery.On (b)(6) 2022, 115 days post index procedure, 100% stenosis noted in right proximal superficial femoral artery and right external iliac artery were treated by placing bypass graft from right external iliac artery to right superficial artery.On the same day, aspiration thrombectomy of the right posterior tibial artery and fasciotomy of all four compartment in the lower right leg were performed.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.

Event Description

Elegance study it was reported that a target lesion revascularization (tlr) occurred.The subject underwent treatment with ranger drug-coated balloon on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the right common femoral artery, right external iliac artery and right proximal superficial femoral artery (sfa).The lesion had a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm, with a lesion length of 60 mm.The lesion was 50% stenosed and classified as tasc ii b.Prior to target lesion treatment with study device, pre-dilatation was performed using 6mm x 40mm mustang pta balloon.Treatment of target lesion was performed by study device, 6 mm x 80 mm ranger drug-coated balloon.Following placement of a 5mm x 40mm innova bare metal stent, the final residual stenosis was noted to be 0%.On (b)(6) 2022, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2022, the subject experienced symptoms of acute limb ischemia in the right leg.On the same day, subject was admitted to the hospital.On (b)(6) 2022, 114 days post-index procedure, 100% stenosis was noted in the right external iliac artery, internal iliac artery, right proximal sfa and posterior tibial artery were treated with mechanical thrombectomy followed by catheter-directed thrombolysis.Post procedure, the final residual stenosis was noted to be 20%.On (b)(6) 2022, the stenosis noted in lower right leg was treated with dacron interposition grafting, thrombectomy and fasciotomy.Updated clinical information indicated that the percentage of stenosis post-treatment on (b)(6) 2022 was in fact still 100% (not the 20% that was previously reported).Further details were given regarding treatment of the stenosis on (b)(6) 2022.The 100% stenosis noted in right proximal superficial femoral artery and external iliac artery was treated with longitudinal arteriotomy, and previously placed stent in right sfa and external iliac artery were removed followed by thrombectomy in the proximal and distal sfa which revealed good inflow and moderate backflow.Subsequently an 8mm dacron interposition grafting was performed form the external iliac artery to the superficial femoral artery.Post-procedure, angiogram reveled dissection of hunter's canal and p2 segment popliteal artery following which 6 mm x 60 mm eluvia stent was placed in sfa and 5 mm x 80 mm supera stent was placed in popliteal artery.On the same day, fasciotomy of all four compartment in the lower leg was performed.Post procedure, the final residual stenosis was noted to be 0%.Clinical information again updated the percentage of stenosis post-treatment on (b)(6) 2022 to 50% (not the 20% or 100% previously reported).Clinical information was again updated, this changed some of the information that was previously reported.The patient had started experiencing right leg pain (b)(6) 2022.On (b)(6) 2022, after being admitted to the hospital, the subject's right leg was cool when compared with the other leg with several areas of livid discoloration in the region of d1 on the right leg.Subject also reported to have tingling paresthesia.Additionally, sonography revealed inguinal pulses and pulses at more distal sites of the right side were not palpable, with only venous flow patterns being observed on the right side.A ct angiography (performed (b)(6) 2022) which revealed in-stent stenosis of the right external iliac artery, and occlusion of the right external iliac artery, right common femoral artery, and right superficial femoral artery.On (b)(6) 2022, 115 days post index procedure, 100% stenosis noted in right proximal superficial femoral artery and right external iliac artery were treated by placing bypass graft from right external iliac artery to right superficial artery.On the same day, aspiration thrombectomy of the right posterior tibial artery and fasciotomy of all four compartment in the lower right leg were performed.Additional information updated the onset of the right leg pain from (b)(6) 2022 to (b)(6) 2022.On (b)(6) 2023 the event was considered resolved.Additional information removed the right common femoral artery from the initially treated target lesion on (b)(6) 2022.

• Brand Name: RANGER
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 16240263
• MDR Text Key: 308085201
• Report Number: 2124215-2023-00510
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1177-01
• Device Catalogue Number: 1177-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Race: White