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

Model Number	RMT281414
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the gore¿ excluder¿ aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, endoleak and component migration.
Event or Problem Description
On (b)(6) 2011, the patient was treated for an abdominal aortic aneurysm.The physician implanted four gore¿ excluder¿ aaa endoprostheses.The procedure was successful, and the patient tolerated the procedure.On 5-apr-2021, the gore fsa was sent images by a physician for a patient that they would like considered for the (b)(6) trial.The rmt281414 had migrated, and was now lying sideways in the aneurysmal sac, resulting in a type ia endoleak.No decision has been made regarding reintervention at this time.Images were returned for evaluation.The evaluation stated: the previously implanted endograft appears to be approximately 45mm distal to the lowest renal artery.The aortic diameter just distal to the lowest renal artery ~ 42mm (average) no pre-implantation images are available to assess diameters and lengths.The aorta appears tortuous.There is no evidence of graft kinking or abnormality within the graft excluding the fact that it appears 4cm distal to the lowest renal artery.The left hypo appears to have been covered during the device placement.There does not appear to be any evidence of a type 1b endoleak.
Additional Manufacturer Narrative
Further review has determined that this event is not reportable, and the medwatch is retracted.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11777645
• Report Number: 3007284313-2021-01418
• Device Sequence Number: 3998102
• Product Code: MIH
• UDI-Device Identifier: 00733132610716
• UDI-Public: 00733132610716
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

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: 06/30/2014
• Device Model Number: RMT281414
• Device Catalogue Number: RMT281414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 05/21/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 62 YR