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

Catalog Number	PXT261416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices implanted and/or related to this event: pxc161200/06762384, udi (b)(4) and pxc201000/7732669, udi (b)(4).Patient medications: furosemide, atorvastatin, paroxetine, aspirin, and omeprazole.The review of the manufacturing paperwork verified that these lots met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, warns that adverse events that may occur and /or require intervention include, but are not limited to endoleak.
Event or Problem Description
On (b)(6) 2010, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that non-contrast scans (date is unknown), revealed the patient¿s aneurysm sac is now 98mm (beginning measurement is unknown).The endoleak source is unknown and cannot be identified by scans done.The physician chose to reintervene on (b)(6) 2019, and extended proximal with an aortic extender endoprosthesis (pla280300/18401586).Then, extended distal in the right external iliac artery, he embolized the hypogastric artery and extended into the right external iliac artery with a contralateral leg endoprosthesis (plc141400/18460240).The final angio run showed a type ii endoleak from the internal mesenteric artery and no type i endoleak.The physician is taking a wait and watch approach on the type ii endoleak.The patient tolerated the reintervention procedure.

• 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: 8282775
• Report Number: 2953161-2019-00008
• Device Sequence Number: 19368221
• Product Code: MIH
• UDI-Device Identifier: 00733132610235
• UDI-Public: 00733132610235
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/02/2019

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 Date: 04/30/2013
• Device Catalogue Number: PXT261416
• Device Lot Number: 7883004
• 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: 01/28/2019
• 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: 76 YR
• Patient Weight: 86