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

Catalog Number HT076080

Device Problem Complete Blockage (1094)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

H6-b15: gore received an adverse event alert from a study database.The ecrf was reviewed and the provided information was captured in sections a through e.H6-b14: a review of the manufacturing records indicated the device met pre-release specifications.H6-b20 and h3-other: the device remains implanted in the patient.Therefore a device evaluation could not be performed.Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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

Gore received an adverse event alert from a retrospective vascular graft study.The patient history includes peripheral artery disease (pad), diagnosed in 2016, requiring femoro-popliteal bypass (not further specified) surgery on the right leg and stenting of arteries, and aorto-bi-femoral bypass (not further specified) surgery because of an abdominal aneurysm previously.On (b)(6) 2016, the patient underwent axillary-femoral bypass surgery for occlusive disease in the right leg with a gore® propaten® vascular graft including heparin use during the procedure.The device was implanted and retained and no adverse events were reported during the procedure.On (b)(6) 2016, the patient presented with gore® propaten® vascular graft bypass thrombosis.Reportedly the thrombosis was related to the index procedure.Medical treatment was performed, a reintervention was not required.The thrombosis was resolved on the same day without sequelae.It was reported, that due to this incident, the patient had to remain hospitalized for a longer period of time than usual.On (b)(6) 2016, the patient was discharged to home.

Manufacturer Narrative

Cause investigation and conclusion: gore received an adverse event alert from study database.The ecfr was reviewed and the provided information is captured in sections 2.And 3.A review of the manufacturing records indicated the device met pre-release specifications.The device remains implanted and was, therefore, not available for analysis.Clinical images enabling direct assessment of product performance were not available for evaluation.Based on the event description and the subsequent investigation we are unable to determine the cause of this incident and assign a root cause.This complaint was initiated based on information received from a study alert.Neither the device nor clinical images enabling direct assessment of product performance were available for evaluation.The available information documented in the study database does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred.The reported device occlusion represents a known complication or adverse event that can occur when using vascular prosthesis and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen, patient-related risk factors and disease progression.In the study database it is documented that the thrombosis was related to the index procedure.This could not be independently confirmed during the investigation based on the available information.The gore® propaten® vascular graft instructions for use (ifu), for the appropriate region and time-period, was reviewed with respect to the complaint detail, and there are applicable statements.The ifu states the following: possible complications with the use of any vascular prosthesis complications which may occur in conjunction with the use of any vascular prosthesis include but are not limited to: thrombosis.

• Brand Name: GORE® PROPATEN® 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: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17498692
• MDR Text Key: 320790644
• Report Number: 2017233-2023-04191
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): Y
• Reporter Country Code: FR
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2019
• Device Catalogue Number: HT076080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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): Hospitalization
• Patient Age: 77 YR
• Patient Sex: Male