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

Device Problem Off-Label Use (1494)

Patient Problem Pulmonary Valve Insufficiency/ Regurgitation (4452)

Event Date 02/01/2021

Event Type  Death  

Manufacturer Narrative

Cheul lee, chang-ha lee, jae gun kwak, jin young song, woo-sup shim, eun young choi, sang yun lee, yang min kim, bicuspid pulmonary valve implantation using polytetrafluoroethylene membrane: early results and assessment of the valve function by magnetic resonance imaging, european journal of cardio-thoracic surgery, volume 43, issue 3, march 2013, pages 468¿472, https://doi.Org/10.1093/ejcts/ezs381.The gore® preclude® pericardial membrane instructions for use note this device is indicated for reconstruction or repair of the pericardium.Additionally stated: "use of the product in applications other than those indicated has the potential for serious complications, such as suture pullout or failure of the repair.".

Event Description

This information was received through literature article "bicuspid pulmonary valve implantation using polytetrafluorethylene membrane: early results and assessment of the valve function by magnetic resonance imaging" published in the european journal of cardio-thoracic surgery, 2 july 2012.The objectives of this study were to evaluation the early results of polytetrafluoroethylene (ptfe) bicuspid pulmonary valve (pv) implantation and to better define the function of this valve by magnetic resonance imaging.Bicuspid pv implantation was performed using a 0.1 mm-thickness gore preclude pericardial membrane.The bicuspid valve is cut from a folded sheet of ptfe membrane.The width of the free edge is 1.8 times the anticipated valve diameter.The length was adjusted to the length of the rvot incision.After placing two anchoring sutures at the level of pv annulus, the posterior leaflet is sewn from its apex towards the free edge using 5/0 polypropylene continuous suture.The anterior leaflet is sewn from its apex towards the free edge, beginning at the vertex of the rvot incision.The article reports one early death.A (b)(6) boy, who had undergone a repair of the double outlet right ventricle at the age of 7 years, died of ventricular dysfunction and multiple organ failure 4 days after operation despite extracorporeal membrane oxygenation support.

• 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
• Manufacturer (Section G): MEDICAL DEER VALLEY B/P; 24416 n. 19th avenue; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11392653
• MDR Text Key: 234010390
• Report Number: 3007284313-2021-01270
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K012098
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2021
• 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
• Patient Outcome(s): Death
• Patient Age: 17 YR