MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE-TEX® STRETCH VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number SA2404

Device Problem Partial Blockage (1065)

Patient Problem Stenosis (2263)

Event Date 11/30/2023

Event Type  Injury  

Manufacturer Narrative

W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

The following was reported to gore: my child was implanted with a ¿masa valve¿ in 2017 built with the off label use of goretex stretch graft and preclude pericardial membrane.The valve failed in 2021.Multiple issues were identified by the surgeon who removed the masa valve, one: the stitching of the sutures of a leaflet tearing and the leaflet ¿was flopping in the wind¿ would you be able to help my son and i file a maude adverse event report? it is not your product that failed but the off label use by the surgeons who failed to give informed consent that failed my child.Additional information received on december 6, 2023: date of implant (b)(6), 2017.Patient had chf in (b)(6) 2022.Valve had failed february 2022, leaflets sutures had come loose "flopping" in the wind, also calcium buildup and stenosis of the conduit.The devices were explanted on (b)(6), 2022.It was reported it was a ross procedure.Regurgitive aortic valve - surgeon recommended masa valve in place of pulmonary valve.Additional note: it was reported on december 7, 2023 that the patient is doing well.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met all pre-release specifications.Engineering evaluation: the identity of the returned device is consistent with the device described in the case but could not be confirmed due to the condition of the returned device.The condition of the returned device is consistent with the case description.The reported failure mode reflects the case description but could not be confirmed.The examination of the returned device and device history records found no anomalies attributable to the manufacture of the device.Explant evaluation: specimens 4-8: the specimens were irregularly shaped eptfe graft fragments that were generally devoid of tissue.Specimens 4 and 7 had blue line markings present, consistent with a gore stretch graft pattern.The largest specimen measured approximately 30 x 6 mm and the smallest measured approximately 20 x 4 mm (at their largest aspects).All edges of the specimens were transected.A suture needle hole was present on specimen 7.Multiple evenly spaced serration marks were present on all of the specimens, except for specimen 4.The serration marks and transections were consistent with interaction with surgical instrumentation (i.E., scalpel/scissors, forceps/clamps), which were likely used during a surgical procedure.

Event Description

The following information was reported to w.L.Gore & associates: "my child was implanted with a 'masa valve' in 2017 built with the off label use of goretex stretch graft and preclude pericardial membrane.The valve failed in 2021.Multiple issues were identified by the surgeon who removed the masa valve, one: the stitching of the sutures of a leaflet tearing and the leaflet ¿was flopping in the wind¿ it is not your product that failed but the off label use by the surgeons who failed to give informed consent that failed my child." additional information received on december 8, 2023, via medical records: on (b)(6) 2017, aortic valve repair.On (b)(6) 2017, patient developed severe aortic insufficiency after valve repair (b)(6) 2017.Patient taken back to operating room for a ross procedure using a gore® preclude® pericardial membrane and a gore-tex® stretch vascular graft for replacement of the native pulmonary valve and pulmonary artery.The patient presented in (b)(6) 2022 with stenosis of the conduit and severe pulmonary regurgitation.The gore® preclude® pericardial membrane and a gore-tex® stretch vascular graft were explanted on (b)(6) 2022.Additional note: it was reported on (b)(6) 2023, that the patient is doing well.

• Brand Name: GORE-TEX® STRETCH VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• 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: nick lafave ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18305058
• MDR Text Key: 330226847
• Report Number: 2017233-2023-04464
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00733132611744
• UDI-Public: 00733132611744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2022
• Device Catalogue Number: SA2404
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/30/2023
• Date Device Manufactured: 01/23/2017
• 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): Other; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male