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

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2018

Event Type  Injury  

Manufacturer Narrative

Article citation: matsushima s, hess a, lammerzahl jr, karliova i, abdul-khaliq h, schafers h-j.Unicuspid aortic valve repair with bicuspidization in the paediatric population.Eur j cardiothorac surg 2020; doi: 10.1093/ejcts/ezaa285.As the date of event is unknown, the event date used will be date of publication, 9 october 2020.The article provided the following patient identifiers: male 49/60, median age 13, median weight 54kg.As the identifiers for each patient were not provided, the above will be used.

Event 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 expanded polytetrafluoroethylene (eptfe) used in 4 patients.It was reported that two out of 4 patients (50%) with eptfe membrane required aortic valve reoperation due to suture dehiscence (n = 1) and unknown cause (n = 1).

Event 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 gore® preclude® pericardial membrane (expanded polytetrafluoroethylene membrane) has been applied.There were 60 consecutive patients with 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 suture dehiscence (n = 1).Date of implant (b)(6) 2014 and date of reoperation (b)(6) 2018.

• Brand Name: GORE PRECLUDE PERICARDIAL MEMBRANE
• Type of Device: 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: 11294406
• MDR Text Key: 230758797
• Report Number: 3007284313-2021-01240
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• PMA/PMN Number: K012098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/06/2019
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 55