MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® BIFURCATED ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Device Problems Material Puncture/Hole (1504); Material Split, Cut or Torn (4008)

Patient Problems Aneurysm (1708); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 12/31/2022

Event Type  Injury  

Manufacturer Narrative

The following article was reviewed: silva, e., nunes, c., baldaia, l., castro, m., oliveira, v.C., silva, j.And antunes, l.F., 2023, february.Giant sac growth: a hybrid approach to treat a misdiagnosed late type iiib endoleak.In ejves vascular forum.Elsevier.In this case report three incidents were reported.They were submitted with gore reference numbers (b)(4) (b)(4) and (b)(4).The manufacturer report numbers are not available at the time of submission.A1: no patient identified was been provided within the literature.Therefore the w.L.Gore reference number was used instead.B3: the exact date the event occurred remains unknown.Therefore (b)(6) 2022 was used as a best estimate.D6a: the exact implant date remains unknown.Therefore (b)(6) 2003 was used as a best estimate.D10: balloon expandable covered stent of unknown make or model.H6-code b13: the author was requested to provide additional information to the incidents reported within the case report.Also serial numbers of the implanted devices, dates of procedures and onset dates of the events have been requested.Further more dicom imaging dataset have been asked to be shared with gore for evaluation.The answer is pending.H3- other: the actual device involved in the adverse event is not readily accessible for testing as it remains implanted in patient.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 article was reviewed: silva, e., nunes, c., baldaia, l., castro, m., oliveira, v.C., silva, j.And antunes, l.F., 2023, february.Giant sac growth: a hybrid approach to treat a misdiagnosed late type iiib endoleak.In ejves vascular forum.Elsevier.The article is a single case study of a patient presenting with an abdominal aortic aneurysm who was treated with a gore® excluder® aaa endoprosthesis on an unknown date in 2003.In 2009, aneurysm growth caused by a type iii endoleak was detected in the area of the connection between the ipsilateral leg and iliac extender.The patient was treated with the relining of the endoprosthesis with a balloon expandable covered stent.The patient tolerated the procedure (this incident is submitted with gore reference number (b)(4)).On an unknown date following the procedure, more aneurysm growth was detected via ultrasound and ct imaging.The physician determined that the aneurysm growth was due to a type ii endoleak.In 2010, the right internal iliac artery and collateral arteries were coil embolized and the aneurysm was injected with thrombin.The patient tolerated the procedure (this incident is submitted with gore reference number (b)(4)).On an unknown date in 2022, the patient presented at the emergency room in a hypotensive and tachycardic (109 bpm) state, with a blood pressure of 64/31 mmhg, pale skin, cold extremities and local tenderness at the right illiac regions of the chest.Ct imaging showed blood in the abdominal cavity near the aneurysm.No endoleak was visible.The patient was treated with emergency open surgery.No type ii endoleak could be identified but a fissure like tear was noted in the endograft at the right iliac limb, contributing to a type iii endoleak.The patient was treated with surgical repair and tolerated the procedure (this incident is submitted with present gore reference number (b)(4)).The cause of the type iii endoleak is not given.

Manufacturer Narrative

Corrected device and manufacturing site.

Manufacturer Narrative

Several requests were emailed to the corresponding author to provide additional information regarding this event.Serial numbers, event dates and dicom imaging were requested but not provided.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.According to the gore® excluder® bifurcated endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to endoleak.

Manufacturer Narrative

Corrected product details in section d and g.

• Brand Name: GORE® EXCLUDER® BIFURCATED ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16748676
• MDR Text Key: 313397561
• Report Number: 3007284313-2023-02442
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/23/2023

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 04/16/2023
• Supplement Dates Manufacturer Received: 10/21/2023; 11/23/2023; 11/23/2023
• Supplement Dates FDA Received: 10/21/2023; 11/23/2023; 11/23/2023
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 93 YR
• Patient Sex: Male