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 Hematoma (1884); Vascular Dissection (3160)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6)study it was reported that vessel dissection occurred.The subject underwent treatment with the ranger drug coated balloons and eluvia drug eluting stents on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left proximal superficial femoral artery extending to left mid superficial femoral artery with proximal reference vessel diameter of 2 mm and distal reference vessel diameter of 4 mm with lesion length of 140 mm and 70% stenosis.Prior to target lesion treatment, pre-dilatation was performed with 5 mm x 100 mm non-boston scientific drug coated balloon.Treatment of target lesion was performed by dilation with study devices, ranger drug coated balloon of 5.0 mm x 120 mm and 5.0 mm x 150 mm followed by placement of eluvia drug eluting stents of 6 mm x 80 mm and 6.0 mm x 60 mm, respectively.On (b)(6) 2022, post the treatment of target lesion with study devices, ranger drug coated balloon of sizes 5 mm x 120 mm and 5 mm x 150 mm, angiography was performed which revealed non flow limiting dissection of grade c in the proximal superficial femoral artery.Site confirmed, dissection was noted due to ranger drug coated balloon 5 x 150 mm.Subsequently, dissection noted was treated with the placement of two eluvia stents of 6.0 mm x 80 mm and 6.0 mm x 60 mm stents respectively in an overlapping manner and post dilated with non-boston scientific 5.0 x 100 mm balloon.Post treatment, angiography performed revealed no evidence of distal embolization or dissection and the final residual stenosis was unknown.On the same day, the event left superficial femoral artery dissection was considered resolved.However, post procedure was complicated by hematoma and acute blood loss anemia.Subject was found to be concerned and slightly diaphoretic with systolic blood pressure ranging between 76 and 122.Subject was transferred to icu setting for overnight observation.On (b)(6) 2022, the subject was discharged from the hospital with the further follow up to be performed on (b)(6) 2022.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14366073
• MDR Text Key: 291465496
• Report Number: 2134265-2022-05225
• Device Sequence Number: 1
• Product Code: ONU
• UDI-Device Identifier: 08714729976028
• UDI-Public: 08714729976028
• 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
• Report Date: 05/11/2022

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: 05/15/2022
• Device Model Number: 1973-03
• Device Catalogue Number: 1973-03
• Device Lot Number: 07645H20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/18/2022
• Initial Date FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female
• Patient Race: White