MAUDE Adverse Event Report: BOSTON SCIENTIFIC VALVELESS HEMASHIELD CONDUIT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

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

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

A moderate to severe decreased in ventricular function was identified.16 years post implant the 20-mm valveless hemashield conduit between the left ventricle and pulmonary artery was stented and a transcatheter bioprosthetic valve was implanted.No additional adverse patient effects were reported.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: VALVELESS HEMASHIELD CONDUIT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 17532063
• MDR Text Key: 321134099
• Report Number: MW5138973
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1