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

Catalog Number PLL161207J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 06/29/2021

Event Type  Injury  

Manufacturer Narrative

Event Description

The following information was reported to gore: on (b)(6), 2021, this patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis to treat non-gore device¿s (endurant) endoleak.Bilateral limbs were extended using contralateral leg endoprosthesis and iliac extender endoprosthesis.It was reported that no obvious endoleak was confirmed.The patient tolerated the procedure.On (b)(6), 2021, follow-up computed tomography image revealed residual distal type i endoleak of the left limb.On (b)(6), 2021, the patient underwent reintervention.The left internal iliac artery was embolized, and an additional stent graft was deployed to the left external iliac artery.The patient tolerated the procedure.The physician stated that the endoleak would had disappeared this time.The fsa stated as follows; the left common iliac artery was extended on (b)(6) but it was as short as 2 cm and calcification was also observed.So that the distal type i endoleak might had remained.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: samir kulovic ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12186522
• MDR Text Key: 267262428
• Report Number: 3013164176-2021-01215
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/18/2021

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: 12/06/2023
• Device Catalogue Number: PLL161207J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/01/2021
• Initial Date FDA Received: 07/18/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/07/2020
• 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): Required Intervention
• Patient Age: 82 YR