MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/02/2016

Event Type  Death  

Manufacturer Narrative

Patient demographics: provided mean age was (b)(6) years old and gender of article is 48 (54.5%) male and 40 (45.5%) female.Patient information will reflect (b)(6)-year-old male.Implanted date is not available.

Event Description

The following information was received through literature ¿early and intermediate-term results of the extracardiac conduit total cavopulmonary connection for functional single-ventricle hearts¿ published in journal of the formosan medical association.The study aimed to analyze the early and intermediate-term results of extracardiac conduit total cavopulmonary connection (ec-tcpc) procedure in 88 patients implanted with gore-tex vascular graft from 2000 to 2013.Late death occurred in the following patients and cause was, conduit thrombosis due to high pulmonary vascular resistance in two patients.

Manufacturer Narrative

G3/g4: add pma/510k number article citation: early and intermediate-term results of the extracardiac conduit total cavopulmonary connection for functional single-ventricle hearts.J.-y.Pan, jen-ping chang, et al.Http://dx.Doi.Org/10.1016/j.Jfma.2015.12.011.Journal of the formosan medical association (2016) 115, 318-324.A review of the manufacturing records for the device was unable to be conducted as no lot number was available.It is unknown if these adverse events were related to the vascular grafts.Information was not made available.Cause of the event cannot be established based on the available information.Further information regarding this event was requested by gore, but no further information has been reported, therefore this investigation is considered complete.

Manufacturer Narrative

B5 - update event description.G3/g4 - update date received by manufacturer.H1/h2 - correct type of reportable event from death to not-reportable.H11 - corrected data.Further review determined that there was no alleged gore device-related event.The information from this literature is determined not reportable.The initial medwatch submitted under manufacturer report number 2017233-2021-02093 was submitted in error, and is hereby retracted.Further review determined that there was no alleged gore device-related event.The information from this literature is determined not reportable.The initial medwatch submitted under manufacturer report number 2017233-2021-02093 was submitted in error, and is hereby retracted.

Event Description

The following information was received through literature ¿early and intermediate-term results of the extracardiac conduit total cavopulmonary connection for functional single-ventricle hearts¿ published in journal of the formosan medical association.The study aimed to analyze the early and intermediate-term results of extracardiac conduit total cavopulmonary connection (ec-tcpc) procedure in 88 patients implanted with gore-tex vascular graft from 2000 to 2013.The cause of late death was conduit thrombosis due to high pulmonary vascular resistance in two patients.The thrombosis information in this literature does not allege the events were related to gore-tex vascular graft, but due to high pulmonary vascular resistance.

• Brand Name: GORE-TEX® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND GREATER DIAMETER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12022979
• MDR Text Key: 257107486
• Report Number: 2017233-2021-02093
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K802095
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2021
• 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: 02/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 6 YR
• Patient Sex: Male
• Patient Weight: 20 KG