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

Model Number RLT351414

Device Problem Material Separation (1562)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

Patient identifier was not provided to gore.Therefore, the gore complaint reference number was used instead.(b)(6) 2015: the distal portion of the olive tip stylet is visible proximal to the previously implanted excluder device.(b)(6) 2019: the proximal olive tip and stylet are visible within the distal arch/proximal descending thoracic aorta.Based on the event description and the subsequent investigation, we are unable to determine the cause of this incident and assign a root cause.

Event Description

On (b)(6) 2015, the patient presented with an abdominal aortic aneurysm and underwent a successful endovascular aortic repair with a gore® excluder® aaa endoprosthesis.After this, the patient underwent annual follow up x-ray imaging with no abnormalities detected.When the patient was scanned in (b)(6) 2021 the reviewing physician realized that an apparent olive tip from a gore stent graft remained in the patient.They are not sure which olive tip remains in the patient, most probable it is the tip of the delivery catheter of the implanted gore® excluder® aaa endoprosthesis trunk-ipsilateral leg endoprosthesis (rlt351414 device).

Event Description

On (b)(6) 2015, the patient presented with an abdominal aortic aneurysm and underwent a successful endovascular aortic repair with a gore® excluder® aaa endoprosthesis.After this, the patient underwent annual follow up x-ray imaging with no abnormalities detected.When the patient was scanned in (b)(6) 2021 the reviewing physician realized that an apparent olive tip from a gore stent graft remained in the patient.They are not sure which olive tip remains in the patient, most probable it is the tip of the delivery catheter of the implanted gore® excluder® aaa endoprosthesis trunk-ipsilateral leg endoprosthesis (rlt351414 device).It was reported that the patient remains asymptomatic and is doing well.No reintervention will be performed.

Manufacturer Narrative

A1: the patients initials were provided and used as the patient identifier.B5: the event description was updated.Health effect - clinical code 4582 is removed from section h6.

Manufacturer Narrative

Corrected g1: manufacturing site.Added g3/g4, h1/h2 and h6.

• Brand Name: GORE® EXCLUDER® AAA 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 MOUNTAIN B/P; 3750 w kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12964375
• MDR Text Key: 287257191
• Report Number: 3007284313-2021-01698
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618477
• UDI-Public: 00733132618477
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/13/2018
• Device Model Number: RLT351414
• Device Catalogue Number: RLT351414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 03/01/2022; 06/14/2022
• Supplement Dates FDA Received: 03/02/2022; 06/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2015
• 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 Age: 82 YR
• Patient Sex: Female