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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE EXCLUDER AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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W. L. GORE & ASSOCIATES, INC. GORE EXCLUDER AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number RLT231418
Medical Device Problem Code Obstruction of Flow (2423)
Health Effect - Clinical Code Pain (1994)
Date of Event 06/03/2021
Type of Reportable Event Serious Injury
Event or Problem Description
On (b)(6) 2020, the patient was treated for an abdominal aortic aneurysm.A gore® excluder® aaa endoprosthesis featuring c3® delivery system was implanted, along with a gore® excluder® aaa endoprosthesis.The patient tolerated the procedure.On (b)(6) 2021, the patient reported emergently with leg pain after strenuous work.Imaging revealed the left leg of the trunk device was completely occluded.The patient was transferred to a hospital in madison, wi for treatment.There, dr.Archer did an open procedure and explanted the device.Patient outcome is unknown at this time.The physician has no opinion regarding the cause of the occlusion.
 
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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
MDR Report Key12075765
Report Number3007284313-2021-01483
Device Sequence Number14309814
Product Code MIH
UDI-Device Identifier00733132622399
UDI-Public00733132622399
Combination Product (Y/N)N
Initial Reporter StateIA
Initial Reporter CountryUS
PMA/510(K) Number
P020004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/28/2021
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
Operator of Device Health Professional
Device Expiration Date02/03/2023
Device Model NumberRLT231418
Device Catalogue NumberRLT231418
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/04/2021
Initial Report FDA Received Date06/28/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age68 YR
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