MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problems Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919)

Patient Problems Hemorrhage/Bleeding (1888); Ischemia (1942); Ischemia Stroke (4418); Ruptured Aneurysm (4436); Aspiration Pneumonitis (4455)

Event Date 10/02/2021

Event Type  Death  

Event Description

The following literature article was reviewed: dueppers, p., reutersberg, b., rancic, z., messmer, f., menges, a.-l., meuli, l., rychla, m.And zimmermann, a.(2022).'long-term results of total endovascular repair of arch-involving aortic pathologies using parallel grafts for supra-aortic debranching', journal of vascular surgery, 75(3), pp.813-823.Long-term morphology and clinical outcome after thoracic endovascular aortic repair combined with parallel grafts (pg-tevar) for arch-involving aortic pathologies was evaluated.A total of 33 patients was included in this single-center, retrospective cohort study from november 2010 to april 2018, receiving 47 gore® tag® thoracic endoprosthesis, 79 gore® viabahn® endoprosthesis, and 1 gore® excluder® iliac branch endoprosthesis.Intraoperative complications included pg dislocation for 2 patients, iliac artery rupture and infrarenal aortic dissection for 1 patient, disconnection of two aortic stent grafts with a type iii endoleak for 1 patient, and axillary or iliac artery bleeding for 1 patient.Reinterventions reported included type 1a endoleaks for 5 patients, type 1b gutter-related endoleaks for 2 patients, and graft occlusion for 2 patients needing additional stent grafts.One patient died of recurrent aspiration pneumonia after severe intraoperative stroke, and one patient died after a pg-tevar-related reintervention (persistent hemorrhage due to a type ia endoleak in a ruptured aorta) 30 days after procedure.3 additional patient died during follow-up.The deaths were related to pg-tevar and included aortic rupture due to type ib endoleak, mesenteric ischemia after type 1b endoleak-related reintervention, and therapy limitation after stroke and aspiration pneumonia after a type ia endoleak-related reintervention.

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The patient age reflects the median age of patients in the article.Patient gender: the majority of the subjects were male.No patient specific information regarding the reported events and interventions was provided in the article.The exact date of event is unknown, therefore, the date of which the literature article was published online is used as date of event.Concomitant medical products: gore® tag® conformable thoracic endoprosthesis; gore® excluder® iliac branch endoprosthesis.The location of the devices are unknown (not stated in the article), therefore, no device evaluation can be performed.A review of the manufacturing records for the device could not be conducted because the serial/lot number remains unknown.The initial reporter (author of the article) has been contacted in order to receive more information on the events and patient details.The result is pending.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.

Manufacturer Narrative

Cause investigation and conclusion.W.L.Gore is proactively and systematically gathering, recording and analyzing relevant data on the quality, performance and safety of a device throughout its entire lifetime.One source is literature published by healthcare professionals.In the present case the author was contacted several times to provide additional information related to the complications reported within the literature, furthermore patients information, serial numbers of the devices, dates of procedures and onset dates of the incident have been requested.The author was not responsive to the requests.A unique device identification number was not provided, therefore the manufacturing date and/or production details cannot be determined.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation relative to the potential endoleak described in the literature.The information reported in the literature, regarding the severe intraoperative stroke and the potential endoleaks leading to serious injuries, does not reasonably suggest a potential malfunction or product packaging and/or labeling issue has occurred, and the information provided to gore cannot be connected to a specific gore device.It also remains unknown to which type of gore device the reported incidents are to be assigned.Based on the literature and the subsequent investigation, no further information was provided to gore, therefore we are unable to determine the cause of these incidents and assign root causes.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15331665
• MDR Text Key: 299033937
• Report Number: 2017233-2022-03281
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): Y
• Reporter Country Code: SZ
• PMA/PMN Number: P040037
• 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
• Report Date: 03/31/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/31/2022
• Supplement Dates Manufacturer Received: 03/30/2023
• Supplement Dates FDA Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: SEE H10
• Patient Outcome(s): Death
• Patient Age: 74 YR
• Patient Sex: Male