MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS VASCULAR SD; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20201

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

Patient Problem Restenosis (4576)

Event Date 04/02/2024

Event Type  Injury  

Manufacturer Narrative

Implant date: the implant date is unknown and was estimated to the first day of (b)(6) 2023.

Event Description

It was reported that restenosis occurred.On (b)(6), a 7.0mmx19mmx150cm express vascular sd stent-balloon expandable was implanted for treatment.On april 2, 2024, the patient was diagnosed with fibro mediastinitis and pulmonary vein stenosis in the previously implanted express sd stent.The 80% stenosed target lesion was located in the severely tortuous pulmonary vein artery.An interventional therapy of intrastent restenosis drug-balloon dilation was performed.During the procedure, a 0.18 guidewire was used to cross the lesion with an 8f non-boston scientific guide catheter.A 7.0 mm x 30 mm, 135 cm ranger drug-coated balloon (dcb) was advanced, but the lesion site was relatively serious, it could not cross the lesion even after repeated attempts.The physician then removed the device and treat the lesion with another drug-coated balloon.No complications were reported, and the patient status was stable.It was unknown if the device will be return for analysis.

• Brand Name: EXPRESS VASCULAR SD
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19143581
• MDR Text Key: 340598781
• Report Number: 2124215-2024-23805
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20201
• Device Catalogue Number: 20201
• Device Lot Number: 0030590062
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE: 0.18
• Patient Outcome(s): Other
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 65 KG