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

Device Problem Missing Information (4053)

Patient Problem Thromboembolism (2654)

Event Date 03/01/2021

Event Type  Injury  

Manufacturer Narrative

Article reviewed: intra-extracardiac total cavopulmonary connection for patients with anatomical complexity.Authors: keiichi hirose, md phd; akio ikai, md phd, masaya murata md; hiroki ito, md, hiroshi koshiyama, md, motonari ishidou, md; keisuke ota, md; kentaro watanabe, md; eiji nakatani, phd, and kisaburo sakamoto, md.Source: the annals of thoracic surgery volume 111, issue 3, march 2021, pages 958-965.It is unknown if the reported thromboembolism is attributed to the gore-tex® vascular graft.No intervention was reported; however, this report is being submitted in conservative approach.Further information was requested but has not been made available as of today.Graft lot/serial number was not made available and device disposition is unknown.

Event Description

The following article was reviewed: intra-extracardiac total cavopulmonary connection for patients with anatomical complexity.Authors: keiichi hirose, md phd; akio ikai, md phd, masaya murata md; hiroki ito, md, hiroshi koshiyama, md, motonari ishidou, md; keisuke ota, md; kentaro watanabe, md; eiji nakatani, phd, and kisaburo sakamoto, md.Source: the annals of thoracic surgery volume 111, issue 3, march 2021, pages 958-965.The extracardiac conduit total cavopulmonary connection (etcpc) is the most widely used for fontan modification worldwide.However, there are difficult cases for performing etcpc because of anatomical complexity, such as apicocaval juxtaposition.In 2002, the intra-extracardiac tcpc (ietcpc) was introduced for such cases.A retrospective review (january 1999 to december 2018) was done in a 20-year single-center experience with 316 tcpc patients, to compare etcpc (n=277) and ietcpc (n=39) for mortality and morbidity.Ietcpc was indicated for the cases when the tcpc conduit would be too curved for ordinary etcpc.As an extracardiac conduit or an intra-extracardiac conduit, gore-tex® vascular grafts were used as conduits.Results: the actuarial survival rate in the etcpc and the ietcpc groups at 10 years were 95.1% and 100.0%, respectively.In the multivariate analysis, preoperative superior vena cava pressure and preoperative oxygen saturation were found to be the independent predictor for postoperative mortality.There was also no significant difference in actuarial rate of freedom from late-occurring complications between etcpc and ietcpc groups.In the multivariate analysis, dominant right ventricle and preoperative svc pressure were independent predictors for late-occurring complications.Postoperative mortality: early death occurred in a 1-year, 7-month-old male patient with hypoplastic left heart syndrome who underwent etcpc with fenestration.This patient died of fontan failure from remaining postoperative severe pulmonary stenosis one month after the operation.Fourteen late deaths occurred, due to fontan failure including protein-losing enteropathy and cirrhosis in 6 patients, infection in 5, sudden death in 3, and cerebral bleeding from trauma in one (1) patient that was in the ietcpc group.Postoperative morbidity: reoperation was performed in 23 patients, including atrioventricular valve plasty in 8, tcpc reoperation in 3, aortic valve plasty in 2, aortic valve replacement in 2, pa plasty in 2, and others in 6.All these patients were in the etcpc group.Late-occurring complications except for reoperation were new-onset tachycardia in 8, new-onset bradycardia in 14, protein-losing enteropathy in 11, prolonged pleural effusion in 8, thromboembolism in 8, liver cirrhosis in 4, pulmonary arteriovenous fistula in 3, and plastic bronchitis in 2 (more than 1 complication in a single patient).The article did not specify any specific allegations against the gore-tex® vascular grafts used as conduits in these procedures.

• Brand Name: GORE-TEX STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT, OF 6MM AND LESS 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: genevieve begay ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12064200
• MDR Text Key: 267259667
• Report Number: 2017233-2021-02117
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2021
• 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: 05/27/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other