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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number TGU262610
Medical Device Problem Code Insufficient Device Problem Information (3190)
Health Effect - Clinical Code No Information (3190)
Date of Event 09/18/2019
Type of Reportable Event Death
Additional Manufacturer Narrative
(b)(6).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Per the gore® tag® thoracic endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to death.
 
Event or Problem Description
On (b)(6) 2019, the patient was implanted with conformable gore® tag® thoracic endoprosthesis.It was reported the patient expired on (b)(6) 2019.No additional information related to this event will be made available to gore.Therefore, further investigation is not possible.
 
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Brand Name
AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key9365657
Report Number2017233-2019-01180
Device Sequence Number2972797
Product Code MIH
UDI-Device Identifier00733132617784
UDI-Public00733132617784
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
P040043
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/25/2019
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 Date05/20/2022
Device Catalogue NumberTGU262610
Device Lot Number20918774
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 Date11/22/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Death;
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