MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX CARDIOVASCULAR PATCH; PATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Device Problems Improper or Incorrect Procedure or Method (2017); Patient Device Interaction Problem (4001)

Patient Problems Low Oxygen Saturation (2477); Pulmonary Hypertension (4460)

Event Date 12/01/2006

Event Type  Death  

Manufacturer Narrative

Literature article citation: valved patch for ventricular septal defect with pulmonary arterial hypertension.Abbas afrasiabi, mahmoud samadi, hossein montazergaem, published in asian cardiovascular and thoracic annals, 2006 dec; 14(6):501-4.As the date of event is unknown, the event date used will be december 1, 2006, as the article was published december 2006.The gore-tex® cardiovascular patch instructions for use states: use of this product in applications other than those indicated has the potential for serious complications.

Event Description

This information was received through literature article "valved patch for ventricular septal defect with pulmonary arterial hypertension" abbas afrasiabi, mahmoud samadi, hossein montazergaem, published in asian cardiovascular and thoracic annals, 2006 dec; 14(6):501-4.The articles objective/aim is to report our experience of closure of a large ventricular septal defect (vsd) in patients with severe pulmonary hypertension, using a valved patch.The article reports from march 1998 to december 2004, 16 acyanotic patients aged 2 to 22 years (mean, 7 ± 5.7 years) with a large ventricular septal defect and elevated pulmonary vascular resistance (9.6 ± 3.8 wood units) underwent surgery.A gore-tex patch with a 5¿8 mm longitudinal slit in the center was used.A piece of pericardium was sewn around the slit on one side of the patch, except for the upper quarter.In all patients, the defect was closed with a trimmed patch and the pericardial aspect was placed on the left ventricular side to allow right-to-left shunting.One patient died on postoperative day 5 due to persistent severe pulmonary arterial hypertension, a right-to-left shunt via the valved patch, and low systemic oxygen saturation.The article indicates this is an off label use of the gore device.

• Brand Name: GORE-TEX CARDIOVASCULAR PATCH
• 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 PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11689105
• MDR Text Key: 246203142
• Report Number: 3007284313-2021-01396
• Device Sequence Number: 1
• Product Code: DXZ
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K811841
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• 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: 04/12/2021
• 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: 4 YR