MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	PXT281218
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.(b)(4)- this code is used to describe an endoleak.It is unknown which of the two implanted devices were involved in the reported endoleak.The device information of the additional device is pxc121400/ (b)(4), udi# (b)(4).According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2013, the patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.Pxt281218/(b)(4) , pxc121400/(b)(4) and pxa280300 were implanted in the left side.An endurant leg component (medtronic) was implanted in the right side.On unknown date in (b)(6) 2018, a routine follow-up computed tomography scan identified that there was no endoleak.On (b)(6) 2018, the patient underwent a treatment of a thoracic aortic aneurysm with conformable gore tag® thoracic endoprostheses.A pre-operative computed tomography scan determined a type iii endoleak from the junction of the previously implanted endoprostheses, the pxt281218 and the pxc121400.An additional endoprosthesis was implanted in the left leg to treat the type iii endoleak.The endoleak was resolved.The patient tolerated the procedure.The physician stated that he suspected a junction leak first, but the pre-operative computed tomography scan and an intra-operative dsa indicated that the endoleak was likely a fabric leak of the pxt281218.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PERM)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7800050
• Report Number: 2953161-2018-00075
• Device Sequence Number: 11281871
• Product Code: MIH
• UDI-Device Identifier: 00733132610280
• UDI-Public: 00733132610280
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/31/2018

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 Date: 08/31/2015
• Device Catalogue Number: PXT281218
• Device Lot Number: 10681385
• 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 Date: 08/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR