MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RMT261416
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	03/12/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.The patient was lost to follow up.On (b)(6) 2019, the patient presented to the emergency room.A ct scan revealed type ii endoleaks originating from the l4 and inferior mesenteric arteries.The aneurysm measured 85 mm.On (b)(6) 2019, a reintervention occurred whereby the l4 artery and ima were coil embolized.At the end of the procedure, the patient suffered pooling of blood in the retroperitoneal cavity.It was suspected that the aneurysm sac ruptured.On (b)(6) 2019, the patient underwent an additional ct scan which appeared to show a 5 mm "marble" of calcium present on the anterior wall approximately 15 mm distal to the proximal end of the trunk-ipsilateral leg component.It was suspected that this calcium caused a type iii (hole) endoleak in the device.Therefore, two aortic extender components were implanted to treat the suspected type iii endoleak.Final angiography revealed no pooling in the area of the suspected graft hole.However, additional type ii endoleaks were seen on final angiography.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8497763
• Report Number: 3007284313-2019-00108
• Device Sequence Number: 2675340
• Product Code: MIH
• UDI-Device Identifier: 00733132610648
• UDI-Public: 00733132610648
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/12/2019

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: 12/31/2014
• Device Catalogue Number: RMT261416
• Device Lot Number: 9927829
• 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: 04/09/2019
• 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: 78 YR