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

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

Patient Problems Anemia (1706); Hematoma (1884); Ischemia (1942); Thrombosis/Thrombus (4440)

Event Date 02/12/2022

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier: (b)(6).A2: patient age at time of enrollment :81 years old.

Event Description

Elegance study it was reported that acute limb ischemia occurred, requiring revascularization surgery.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 proximal popliteal artery and right distal popliteal artery with 3 mm proximal reference vessel diameter and 3 mm distal reference vessel diameter with lesion length of 100 mm and 100% stenosis was classified as tasc ii d lesion.Prior to target lesion treatment, the pre-treatment dilation was performed using 5 mm x 150 mm sterling drug coated balloon.Treatment of target lesion was performed by dilation using 4.0 mm x 150 mm ranger drug coated balloon and the final residual stenosis was noted to be 30%.On (b)(6) 2022, subject was noted with symptoms related to the right leg claudication and was hospitalized on the same day for further medical evaluation and treatment.Esophagogastroduodenoscopy (ecd) was performed and in response to the event, balloon angioplasty was performed followed by right superficial femoral artery stenting and thrombectomy.Per edc, the event was considered to be resolved and the subject was later discharged from the hospital.

Event Description

Elegance study: it was reported that acute limb ischemia occurred, requiring revascularization surgery.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 proximal popliteal artery and right distal popliteal artery with 3 mm proximal reference vessel diameter and 3 mm distal reference vessel diameter with lesion length of 100 mm and 100% stenosis was classified as tasc ii d lesion.Prior to target lesion treatment, the pre-treatment dilation was performed using 5 mm x 150 mm sterling drug coated balloon.Treatment of target lesion was performed by dilation using 4.0 mm x 150 mm ranger drug coated balloon and the final residual stenosis was noted to be 30%.On (b)(6) 2022, subject was noted with symptoms related to the right leg claudication and was hospitalized on the same day for further medical evaluation and treatment.Esophagogastroduodenoscopy (ecd) were performed and in response to the event, balloon angioplasty was performed followed by right superficial femoral artery stenting and thrombectomy.Per edc, the event was considered to be resolved and the subject was later discharged from the hospital.It was further reported that during the index procedure, pre-dilation was performed using 4 mm x 150 mm sterling drug coated balloon.Additionally, post-treatment, 6 mm x 80 mm non-boston scientific drug-eluting stent was placed.On (b)(6) 2022, subject visited emergency room (er) with right lower extremity non-focal pain.In er, physical examination revealed palpable dp and pt pulses however, right lower extremity was cool to touch.On the same day, subject was hospitalized for the treatment of right lower extremity critical limb ischemia.On (b)(6) 2023, rutherford classification was noted to be 1 and angiographic findings revealed fresh thrombotic occlusion in right superficial femoral artery and popliteal artery with under-expansion of the sfa and popliteal arteries.Per source, on (b)(6) 2023, 4 days post-index procedure, thrombotic occlusion noted in the right popliteal artery and superficial femoral artery were treated by thrombectomy using a non-bsc thrombectomy device.Subsequently, intravascular ultrasound revealed residual segments of thrombus, which was treated with balloon angioplasty using 5 mm balloon followed by the placement of 6 mm x 140 mm non-boston scientific stent from right distal popliteal artery up to right mid sfa.Post-dilation with 5 mm balloon, brisk flow was noted with no additional thrombus.On (b)(6)2022, the event was considered to be resolved.On (b)(6) 2022, the subject was discharged from the hospital.

Manufacturer Narrative

Sections updated in supplemental report: b5: updated with additional information.H6: patient code added.A1: patient identifier: (b)(6).A2: patient age at time of enrollment: 81 years old.

Event Description

Elegance study.It was reported that acute limb ischemia occurred, requiring revascularization surgery.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 proximal popliteal artery and right distal popliteal artery with 3 mm proximal reference vessel diameter and 3 mm distal reference vessel diameter with lesion length of 100 mm and 100% stenosis was classified as tasc ii d lesion.Prior to target lesion treatment, the pre-treatment dilation was performed using 5 mm x 150 mm sterling drug coated balloon.Treatment of target lesion was performed by dilation using 4.0 mm x 150 mm ranger drug coated balloon and the final residual stenosis was noted to be 30%.On (b)(6) 2022, subject was noted with symptoms related to the right leg claudication and was hospitalized on the same day for further medical evaluation and treatment.Esophagogastroduodenoscopy (ecd) were performed and in response to the event, balloon angioplasty was performed followed by right superficial femoral artery stenting and thrombectomy.Per edc, the event was considered to be resolved and the subject was later discharged from the hospital.It was further reported that during the index procedure, pre-dilation was performed using 4 mm x 150 mm sterling drug coated balloon.Additionally, post-treatment, 6 mm x 80 mm non-boston scientific drug-eluting stent was placed.On (b)(6) 2022, subject visited emergency room (er) with right lower extremity non-focal pain.In er, physical examination revealed palpable dp and pt pulses however, right lower extremity was cool to touch.On the same day, subject was hospitalized for the treatment of right lower extremity critical limb ischemia.On (b)(6) 2023, rutherford classification was noted to be 1 and angiographic findings revealed fresh thrombotic occlusion in right superficial femoral artery and popliteal artery with under-expansion of the sfa and popliteal arteries.Per source, on (b)(6) 2023, 4 days post-index procedure, thrombotic occlusion noted in the right popliteal artery and superficial femoral artery were treated by thrombectomy using a non-bsc thrombectomy device.Subsequently, intravascular ultrasound revealed residual segments of thrombus, which was treated with balloon angioplasty using 5 mm balloon followed by the placement of 6 mm x 140 mm non-boston scientific stent from right distal popliteal artery up to right mid sfa.Post-dilation with 5 mm balloon, brisk flow was noted with no additional thrombus.On (b)(6) 2022, the event was considered to be resolved.On (b)(6) 2022, the subject was discharged from the hospital.It was again further reported that on (b)(6) 2022, ct of abdomen performed revealed small left iliopsoas intramuscular hematoma near however hemoperitoneum or retroperitoneal hematoma were not noted.On (b)(6) 2022, subject had an episode of melena with continued drop of hemoglobin concerning for gi bleeding.On the same day ct of abdomen and pelvis was performed which revealed no evidence of active hemorrhage with stable small left iliopsoas intramuscular hematoma.On (b)(6) 2022, gi was consulted, and esophagogastroduodenoscopy was performed which revealed non-bleeding ulcer in mid esophagus and large ulceration at gastroesophageal junction with 2 visible vessels treated with argon plasma coagulation.During the course of hospitalization, subject was transfused with 7 units of prbc transfusions for blood loss anemia.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.

Manufacturer Narrative

Sections updated in supplemental report: b5- updated with additional information.H6- patient and impact codes added.A1: patient identifier- (b)(6).A2: patient age at time of enrollment- 81 years old.

Manufacturer Narrative

Sections updated in supplemental report: b5- updated with additional inforation.A1: patient identifier- (b)(6).A2: patient age at time of enrollment- 81 years old.

Event Description

Elegance study it was reported that acute limb ischemia occurred, requiring revascularization surgery.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 proximal popliteal artery and right distal popliteal artery with 3 mm proximal reference vessel diameter and 3 mm distal reference vessel diameter with lesion length of 100 mm and 100% stenosis was classified as tasc ii d lesion.Prior to target lesion treatment, the pre-treatment dilation was performed using 5 mm x 150 mm sterling drug coated balloon.Treatment of target lesion was performed by dilation using 4.0 mm x 150 mm ranger drug coated balloon and the final residual stenosis was noted to be 30%.On (b)(6) 2022, subject was noted with symptoms related to the right leg claudication and was hospitalized on the same day for further medical evaluation and treatment.Esophagogastroduodenoscopy (ecd) were performed and in response to the event, balloon angioplasty was performed followed by right superficial femoral artery stenting and thrombectomy.Per edc, the event was considered to be resolved and the subject was later discharged from the hospital.It was further reported that during the index procedure, pre-dilation was performed using 4 mm x 150 mm sterling drug coated balloon.Additionally, post-treatment, 6 mm x 80 mm non-boston scientific drug-eluting stent was placed.On (b)(6) 2022, subject visited emergency room (er) with right lower extremity non-focal pain.In emergency room, physical examination revealed palpable dp and patient pulses however, right lower extremity was cool to touch.On the same day, subject was hospitalized for the treatment of right lower extremity critical limb ischemia.On (b)(6) 2023, rutherford classification was noted to be 1 and angiographic findings revealed fresh thrombotic occlusion in right superficial femoral artery and popliteal artery with under-expansion of the sfa and popliteal arteries.Per source, on (b)(6) 2023, 4 days post-index procedure, thrombotic occlusion noted in the right popliteal artery and superficial femoral artery were treated by thrombectomy using a non-bsc thrombectomy device.Subsequently, intravascular ultrasound revealed residual segments of thrombus, which was treated with balloon angioplasty using 5 mm balloon followed by the placement of 6 mm x 140 mm non-boston scientific stent from right distal popliteal artery up to right mid sfa.Post-dilation with 5 mm balloon, brisk flow was noted with no additional thrombus.On 13-feb-2022, the event was considered to be resolved.On (b)(6) 2022, the subject was discharged from the hospital.It was again further reported that on (b)(6) 2022, ct of abdomen performed revealed small left iliopsoas intramuscular hematoma near however hemoperitoneum or retroperitoneal hematoma were not noted.On (b)(6) 2022, subject had an episode of melena with continued drop of hemoglobin concerning for gi bleeding.On the same day ct of abdomen and pelvis was performed which revealed no evidence of active hemorrhage with stable small left iliopsoas intramuscular hematoma.On (b)(6) 2022, gi was consulted, and esophagogastroduodenoscopy was performed which revealed non-bleeding ulcer in mid esophagus and large ulceration at gastroesophageal junction with 2 visible vessels treated with argon plasma coagulation.During the course of hospitalization, subject was transfused with 7 units of prbc transfusions for blood loss anemia.On (b)(6) 2022, the subject was discharged from the hospital on dual antiplatelet therapy.It was further reported that the target lesion in the index procedure was in the right mid popliteal artery extending up to right distal popliteal artery.

• 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; wuerselen 52146 ; GM 52146
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16740426
• MDR Text Key: 313290943
• Report Number: 2124215-2023-17370
• Device Sequence Number: 1
• Product Code: ONU
• Combination Product (y/n): Y
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 02/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• 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 Sex: Female
• Patient Race: Black Or African American