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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number PLA360400
Medical Device Problem Code Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code Occlusion (1984)
Date of Event 05/29/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
The following was reported to gore: on (b)(6) 2018, the patient presented with an abdominal aortic aneurysm that was treated with gore® excluder® aaa endoprostheses.It was stated that the infrarenal aortic neck was short (8mm).Intraoperatively it was decided to add an aortic extender endoprosthesis (pla).At the end of the procedure it was realized that the pla is partially covering the left renal artery to a minimal extend.On (b)(6) 2018, a post-implantation computer tomography (ct) showed that the left renal artery was fully occluded.Further patient treatment is unknown.
 
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Brand Name
AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
Common Device Name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
MDR Report Key7644722
Report Number2953161-2018-00061
Device Sequence Number125830
Product Code MIH
UDI-Device Identifier00733132618439
UDI-Public00733132618439
Combination Product (Y/N)N
Initial Reporter CountryNL
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) 06/07/2018
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 Date01/05/2020
Device Catalogue NumberPLA360400
Device Lot Number15852294
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 Date06/28/2018
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 Disability;
Patient Age75 YR
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