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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE EXCLUDERAAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Model Number PXA280300
Device Problem Human-Device Interface Problem (2949)
Patient Problem Aneurysm (1708)
Event Date 03/19/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: patient medications include but are not limited to: welchol, xarelto, boniva, synthroid, pantoprazole, vytorin, amlodipine, and gabapentin.Patient medical history includes but is not limited to: gastroesophageal reflux disease, hiatal hernia, basal cell carcinoma, pulmonary embolism, hypertension, and osteoporosis.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states, adverse events that may occur and / or require intervention include but are not limited to: endoleak.
 
Event Description
On (b)(6) 2021, this patient underwent reintervention for treatment of a proximal type i endoleak.A gore® aortic extender component was placed proximally to extend coverage of a previously implanted gore® aortic extender component.Additionally endoanchors were screwed in to obtain secure transmural fixation.The patient tolerated the procedure and the endoleak was reduced but not fully resolved.
 
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Brand Name
GORE EXCLUDERAAA 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 SUNNYVALE B/P
1327 orleans drive
sunnyvale CA 94089
Manufacturer Contact
laura crawford
1505 n. fourth street
flagstaff, AZ 86004
9285263030
MDR Report Key11548072
MDR Text Key242377737
Report Number2953161-2021-01055
Device Sequence Number1
Product Code MIH
UDI-Device Identifier00733132609895
UDI-Public00733132609895
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P020004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Physician
Type of Report Initial
Report Date 03/22/2021
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 Date02/28/2017
Device Model NumberPXA280300
Device Catalogue NumberPXA280300
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/19/2021
Initial Date FDA Received03/22/2021
Date Device Manufactured03/18/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age84 YR
Patient Weight78
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