MAUDE Adverse Event Report: UPMC-CHP/PECA LABS/PECA LABS, INC. MASA VALVE CONSTRUCTED OF 24M M GORETEX STRETCH GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Stenosis (2263); Prolapse (2475); Pulmonary Valve Insufficiency/ Regurgitation (4452); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/14/2017

Event Type  Injury  

Event Description

On (b)(6) 2017 a 14yo patient was implanted with a masa valve constructed of 24m m goretex stretch graft, and the masa valve tri-leaflets constructed of 0.1mm gore tex preclude pericardial membrane 1pcm102 bedside in the operating room by the surgeons.Patient began to experience chest pain, shortness of breath and fatigue in (b)(6) 2021, which continued and increased in severity until the explant of the masa valve in (b)(6) 2022.An echocardiogram in (b)(6) 2022 confirmed the masa valve had failed, as there was a 45% regurgitation of the masa valve.An mri (b)(6) 2022 confirmed failure of the masa valve with a 45% regurgitation.(b)(6) 2022 ct scan confirmed that the masa valve had failed with a 50% regurgitation, of the masa valve leaflets constructed of goretex preclude pericardial membrane, 1pcm102, two prolapsed masa valve leaflets, and one masa valve leaflet torn from the sutures, additionally there was infolding of the 24mm goretex stretch graft, moderate stenosis of the masa valve.The masa valve constructed of 24mm goretex stretch graft, and the masa valve tri-leaflets 0.1mm goretex preclude pericardial membrane 1pcm102 were explanted (b)(6) 2022 and replaced with 28-mm woven hemashield graft and 25-mm edwards magna pericardial bio prosthesis.The materials used to construct the masa valve were used off label, such use w.L.Gore and associates warn of serious consequences including suture dehiscence.

• Brand Name: MASA VALVE CONSTRUCTED OF 24M M GORETEX STRETCH GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): UPMC-CHP/PECA LABS/PECA LABS, INC.
• MDR Report Key: 18970266
• MDR Text Key: 338623212
• Report Number: MW5153099
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Hospitalization; Life Threatening
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 50 KG