MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE PRECLUDE PERICARDIAL MEMBRANE; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Model Number	1PCM102
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/19/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
This information was received through literature article: unicuspid aortic valve repair with bicuspidization in the paediatric population.Matsushima s, hess a, lammerzahl jr, karliova i, abdul-khaliq h, schafers h-j.Eur j cardiothorac surg 2020; doi:10.1093/ejcts/ezaa285.The articles objective was to review the following: aortic stenosis or regurgitation that requires operations in children often results from unicuspid valve morphology.In all paediatric patients with this anomaly, we have performed unicuspid valve repair by bicuspidization, creating a new commissure via adding patch material.This study reviewed our experience with this procedure.The article reports that patients with a unicuspid aortic valve who underwent bicuspidization at <_18 years of age between 2003 and 2018 were evaluated.Autologous pericardium had initially been used for cusp augmentation.Since 2014, decellularized xenogeneic tissue or expanded polytetrafluoroethylene membrane has been applied.There were 60 consecutive patients with gore¿ preclude¿ pericardial membrane (expanded polytetrafluoroethylene eptfe) used in 4 patients.It was reported that one out of 4 patients (50%) with eptfe membrane required aortic valve reoperation due to an unknown cause (n = 1).Date of implant (b)(6) 2016 and date of reoperation (b)(6) 2016.
Additional Manufacturer Narrative
H6: updated investigation findings and conclusion code.

• Brand Name: GORE PRECLUDE PERICARDIAL MEMBRANE
• Common Device Name: PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11444264
• Report Number: 3007284313-2021-01279
• Device Sequence Number: 3618198
• Product Code: DXZ
• UDI-Device Identifier: 00733132601837
• UDI-Public: 00733132601837
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K012098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/30/2019
• Device Model Number: 1PCM102
• Device Catalogue Number: 1PCM102
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/09/2021
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 03/09/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 18 YR
• Patient Weight: 63