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

Catalog Number	PXT231416
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Atrial Perforation (2511)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2010, this patient underwent endovascular repair of an infrarenal abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.It was reported that the patient had a significant aortic neck angle approximately 2-3 cm below the lowest renal artery.On (b)(6) 2018, during follow up angiography, it was suspected that the aortic neck of the trunk-ipsilateral leg component had infolded.This diagnosis was confirmed on a cta performed on (b)(6) 2018.It was reported that the patient has some thrombus and claudication in the lower limbs.A reintervention is planned for (b)(6) 2018.
Additional Manufacturer Narrative
Additional manufacturer narrative/corrected data: reintervention occurred on (b)(6) 2018, whereby two aortic extender components (pla280300) were implanted to treat the proximal infolding of the trunk-ipsilateral leg component.The patient tolerated the 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: 7877873
• Report Number: 3013164176-2018-00082
• Device Sequence Number: 186663
• Product Code: MIH
• UDI-Device Identifier: 00733132610150
• UDI-Public: 00733132610150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Followup,Followup
• Report Date (Section B): 11/07/2018

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 Date: 10/31/2012
• Device Catalogue Number: PXT231416
• Device Lot Number: 7319567
• 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; Not provided
• Initial Report FDA Received Date: 09/14/2018
• Supplement Report FDA Received Date: 10/16/2018; 11/08/2018
• 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: Other