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

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

Patient Problem Vascular Dissection (3160)

Event Date 08/23/2023

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier- (b)(6).A2: patient age at the time of enrollment- 85 years old.

Event Description

Elegance study it was reported that a dissection of grade d occurred.The subject underwent treatment with the ranger drug-coated balloons and eluvia drug-eluting stents on (b)(6) 2023 as a part of the elegance clinical trial.The target lesion was in the right proximal superficial femoral artery, right mid superficial femoral artery extending up to right distal superficial femoral artery with 7 mm proximal reference vessel diameter and 7 mm distal reference vessel diameter with lesion length 250 mm with 90% stenosis and was classified as tasc ii b lesion.Prior to the treatment of target lesion with study device, lithotripsy was performed by using 6 mm x 60 mm non-boston scientific (bsc) lithotripsy device.Treatment of the target lesion was performed by dilation using study devices, 6 mm x 200 mm and 6 mm x 100 mm ranger drug-coated balloons followed by the placement of two 7 mm x 120 mm eluvia drug-eluting stents.Following treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2023, on the same day of index procedure, during the treatment of the target lesion, dissection of grade d was noted in the target lesion due to 6 mm x 200 mm ranger drug-coated balloon.In response to the complication, a bailout stent was placed.Post treatment, the final residual stenosis was noted to be 0%.On (b)(6) 2023, the complication of dissection was resolved.On the same day, the subject was discharged from hospital on aspirin and clopidogrel.

• 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 ; GM
• Manufacturer Contact: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17835350
• MDR Text Key: 324493570
• Report Number: 2124215-2023-52351
• 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
• Report Date: 09/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2023
• 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: 09/06/2023
• 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 Sex: Male
• Patient Race: White