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

Model Number ST0707

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

Patient Problems Hematoma (1884); Seroma (2069)

Event Date 08/02/2014

Event Type  Injury  

Manufacturer Narrative

H3 and h6 code b20: the device remains implanted in the patient.Therefore a device evaluation could not be performed.H6 code b14: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.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

Reportedly on (b)(6) 2014, this patient underwent an endovascular treatment for an extensive occlusive peripheral arterial disease in which a gore-tex® vascular graft was implanted proximally on the left axillary artery and distally to the deep femoral artery.According to reports, an adjunctive procedure was performed and a gore-tex® stretch vascular graft was implanted proximally on the gore-tex® vascular graft and distally to the left supra-articular popliteal artery.Reportedly, the whole procedure was uneventful, no adverse events or complications were recorded and the patency of the devices were confirmed at the end of the procedure.The patient received an additional antiplatelet medication during the procedure and the devices were implanted and retained.According to reports, on august 2 2014 series of adverse events were recorded and this includes the following: "infection of the left axillofemoral prosthesis", a reintervention was performed and the devices were explanted on september 17 2014.Another adverse event alert was recorded on the same date as " severe sepsis with cutaneous origin, left lower limb (bypass scar)" and a reintervention was performed."fluid infiltration around the left axillofemoral bypass" and washing and drainage of the fluid through the surgical site of the left axillofemoral-popliteal bypass were performed on (b)(6) 2014 and (b)(6) 2014 respectively.On (b)(6) 2014, another adverse event termed " hematoma in the proximal part of the left axillary-subclavian bypass" was discovered which necessitated a reintervention.A surgical evacuation of the hematoma was performed, this procedure also involved explantation of the prosthesis and insertion of an aorto-bi-femoral bypass and a left femoro-popliteal bypass.Reportedly on (b)(6) 2014, the patient was pronounced dead.However the physician confirmed that the death of the patient is not related to the gore devices used in this procedure.The cause of death was indicated to be colonic ischemia and multivisceral failure syndrome.2200-a:-other was used to capture hematoma.

Event Description

Reportedly on (b)(6) 2014, this patient underwent an endovascular treatment for an extensive occlusive peripheral arterial disease in which a gore-tex® vascular graft was implanted proximally on the left axillary artery and distally to the deep femoral artery.According to reports, an adjunctive procedure was performed and a gore-tex® stretch vascular graft was implanted proximally on the gore-tex® vascular graft and distally to the left supra-articular popliteal artery.Reportedly, the whole procedure was uneventful, no adverse events or complications were recorded and the patency of the devices were confirmed at the end of the procedure.The patient received an additional antiplatelet medication during the procedure and the devices were implanted and retained.On (b)(6) 2014, an adverse event termed "hematoma in the proximal part of the left axillary-subclavian bypass" was discovered which necessitated a reintervention.A surgical evacuation of the hematoma was performed, this procedure also involved explantation of the prosthesis and insertion of an aorto-bi-femoral bypass and a left femoro-popliteal bypass.Reportedly on (b)(6) 2014, the patient was pronounced dead.However the physician confirmed that the death of the patient is not related to the gore devices used in this procedure.The cause of death was indicated to be colonic ischemia and multivisceral failure syndrome.

Manufacturer Narrative

Cause investigation and conclusion: a review of the manufacturing records, including sterilization records, indicated the lots met all pre-release specifications.Neither images enabling direct assessment of product performance nor the product itself, which was discarded to the facility, were returned for evaluation.Based on the incident description and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of this incident and assign a root cause.No potential new or different reasonably foreseeable risks related to the device or its use were identified based on this event.Ongoing risk/benefit assessment affirms risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore will continue to monitor post-market data closely to ensure that the risk assessment remains accurate.In the instructions for use the following is stated: 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: perigraft hematomas.

Manufacturer Narrative

Remove: e0505 - hematoma.Add: e0307 - seroma.Remove: f2301 - additional device required.Add: d14 - no problem detected.

• 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: wilson okeke ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17256151
• MDR Text Key: 318551443
• Report Number: 2017233-2023-04087
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K903931
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2019
• Device Model Number: ST0707
• Device Catalogue Number: ST0707
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 07/05/2023
• Supplement Dates Manufacturer Received: 09/21/2023; 09/21/2023
• Supplement Dates FDA Received: 09/21/2023; 11/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2014
• 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
• Patient Age: 61 YR
• Patient Sex: Male