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

Model Number	RLT261416
Medical Device Problem Codes	Microbial Contamination of Device (2303); Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm (1708); Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	12/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: gore® excluder® aaa endoprosthesis - stent graft contralateral leg endoprosthesis (b)(4).Gore® excluder® aaa endoprosthesis - stent graft aortic extender endoprosthesis (b)(4).(b)(4).
Event or Problem Description
On (b)(6) 2015, a patient presented with an abdominal aortic aneurysm (measured 50.6 mm) was treated with gore® excluder® aaa endoprosthesis (b)(4).On (b)(6) 2021, the patients was admitted with type ii endoleak and a sudden growth of the aneurysmal sac (80 mm).The endoleak was embolized with some metallic spiral and glue.In was additionally reported that after the procedure the patient started with a fever and covid positive results and was moved to covid ward.
Additional Manufacturer Narrative
H6 code 3331: a review of the manufacturing records indicated the lot met all pre-release specifications.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak.This device is also reported with the manufacturer report number 3007284313-2022-02018 (for an event at a later date).Corrected h6: updated health effect - impact code to 4641 - unexpected medical intervention.Code 4625 was inadvertently entered, but correct code should be 4641.Updated investigation findings code to 213 - no device problem found.Code 3233 is no longer applicable.Updated investigation conclusions code to 4315 and 22.Code 11 is no longer applicable.
Event or Problem Description
After the flogistic index continues to be high a month later, an antibiotic therapy and infective consultation was initiated.
Additional Manufacturer Narrative
B5: additional event description: after the flogistic index continues to be high a month later, an antibiotic therapy and infective consultation was initiated.Per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak, infection (e.G., aneurysm, device or access sites).Corrected h6: updated health effect - clinical codes to e050102 - aneurysm expansion , and e2121 - endoleaks.Updated health effect - impact code to f1901 - additional surgery.Code 4641 was inadvertently entered, but correct code should be f1901.Updated medical device problem code to a180105 - microbial contamination of device, as infective consultation was initiated due to persistent high flogistic index.Updated component code to g07001 - part/component/sub-assembly term not applicable.Code 515 was inadvertently entered, but correct code should be g07001.Removed investigation conclusions code 4315.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Common Device Name: 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14943422
• Report Number: 3007284313-2022-02017
• Device Sequence Number: 6196086
• Product Code: MIH
• UDI-Device Identifier: 00733132622467
• UDI-Public: 00733132622467
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Model Number: RLT261416
• Device Catalogue Number: RLT261416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2022
• Supplement Date Received by Manufacturer: 06/29/2022; 09/13/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 07/27/2022; 09/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 73 KG
• Patient Race: White