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

Catalog Number	PXT231216
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/14/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: patient medications: aspirin, calcium carbonate, celebrex, b12, vicodin, metoprolol, oxybutynin, simvastatin, terazosin, terbinafine, and as needed polyethylene glycol.
Event or Problem Description
On (b)(6) 2007, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that during a routine follow up visit, an ultrasound dated (b)(6) 2019, revealed aneurysm enlargement (5.8cm to 6.3cm).Follow up computed tomography (date unknown) revealed the patient had a type i endoleak with distal migration of the proximal neck of the graft (amount of migration is unknown).There is aneurysm sac enlargement (0.5 cm from last follow up visit in 2013, ct).The physician reintervened on (b)(6) 2019, and implanted a gore® excluder® aaa aortic extender endoprosthesis.The endoleak was resolved and the patient tolerated the procedure.
Event or Problem Description
On (b)(6) 2007, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that during a routine follow up visit, an ultrasound dated (b)(6) 2019, revealed aneurysm enlargement (5.8cm to 6.3cm).Follow up computed tomography (date unknown) revealed the patient had a type i endoleak with distal migration of the proximal neck of the graft (amount of migration is unknown).The physician reintervened on (b)(6) 2019, and implanted a gore® excluder® aaa aortic extender endoprosthesis.The endoleak was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
Correction b5.

• 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: 8628348
• Report Number: 2953161-2019-00042
• Device Sequence Number: 1968793
• Product Code: MIH
• UDI-Device Identifier: 00733132610112
• UDI-Public: 00733132610112
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2007
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2019

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: 07/31/2010
• Device Catalogue Number: PXT231216
• Device Lot Number: 05247920
• 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: 05/21/2019
• Supplement Report FDA Received Date: 07/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10/11.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 77