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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number RLT231214
Date of Event 11/14/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Concomitant medical products -- patient medications: albuterol, alprazolam, and aspirin.The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events which may occur and require intervention include endoleak.
 
Event or Problem Description
On (b)(6) 2018, the patient was implanted with gore® excluder® aaa endoprostheses it was reported that during a routine follow up visit, computed tomography images (date is not known), revealed a proximal type i endoleak.It is unknown if there was aneurysm sac enlargement.The physician reintervened on (b)(6) 2019, and implanted a gore® excluder® aortic extender endoprosthesis.The endoleak was resolved and the patient tolerated the reintervention.
 
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Brand Name
AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key9462165
Report Number3007284313-2019-00374
Device Sequence Number3040587
Product Code MIH
UDI-Device Identifier00733132622337
UDI-Public00733132622337
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
P020004
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/18/2019
1 Device 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 Date02/04/2021
Device Catalogue NumberRLT231214
Device Lot Number17744758
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date12/12/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
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