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

Catalog Number	PXT231418
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/01/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: pxc141400/06603644, pxl161007/06772203 and pxa230300/06501919.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 (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and aneurysm enlargement.Device udi (b)(4).
Event or Problem Description
On (b)(6) 2009, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.After trunk-ipsilateral leg and contralateral leg components (pxt231418/06551039 and pxc141400/06603644) were deployed, aortic extender and iliac extender components (pxl161007/06772203 and pxa230300/06501919) were implanted for proximal and distal extension of the endoprostheses.The procedure was successfully concluded without endoleaks.In 2012, aneurysm enlargement was revealed due to a suspected type ii endoleak originating from a lumbar artery.Exact amount of enlargement was reportedly unknown.A reintervention was performed whereby an aortic extender component was implanted and the aneurysm was embolized using n-butyl-2-cyanoacrylate (nbca).Another follow-up study was performed after the reintervention, confirming that the aneurysm had continued to expand (exact amount of enlargement was unknown).The patient has currently been monitored with aneurysm enlargement.
Additional Manufacturer Narrative
B5: describe event or problem updated the event description.D7: date of device explant put (b)(6) 2018 as the date of device explant.H6: code 22 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, aneurysm enlargement and surgical conversion.
Event or Problem Description
On (b)(6), 2009, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.After trunk-ipsilateral leg and contralateral leg components (pxt231418/06551039 and pxc141400/06603644) were deployed, aortic extender and iliac extender components (pxl161007/06772203 and pxa230300/06501919) were implanted for proximal and distal extension of the endoprostheses.The procedure was successfully concluded without endoleaks.In 2012, aneurysm enlargement was revealed due to a suspected type ii endoleak originating from a lumbar artery.Exact amount of enlargement was reportedly unknown.A reintervention was performed whereby an aortic extender component was implanted and the aneurysm was embolized using n-butyl-2-cyanoacrylate (nbca).Another follow-up study was performed after the reintervention, confirming that the aneurysm had continued to expand (exact amount of enlargement was unknown).On (b)(6), 2018, an open abdominal surgery was performed whereby initially implanted endoprostheses were explanted.On (b)(6), 2018, the patient was discharged from the hospital with good health condition.

• 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: 7849816
• Report Number: 2953161-2018-00079
• Device Sequence Number: 1835440
• Product Code: MIH
• UDI-Device Identifier: 00733132610167
• UDI-Public: 00733132610167
• 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: 2009
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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: 01/31/2012
• Device Catalogue Number: PXT231418
• Device Lot Number: 06551039
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 09/20/2018
• 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: 67 YR