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

Model Number	PLA280300
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that 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) 2021, the patient was implanted with gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.It was reported that the trunk-ipsilateral leg endoprosthesis was deployed and in place.While the physician attempted to cannulate the contralateral gate, the device migrated distally approximately 5mm which caused a proximal type i endoleak.The physician chose to implant an aortic extender endoprosthesis to treat the migration and endoleak.While the device was being deployed, it appeared not to fully expand (flower out).The device was ballooned and expanded.In addition, the device moved proximally during deployment and covered the right renal artery.Regardless of multiple attempts to pull down the device, it could not be adjusted during the procedure.The endoleak was resolved.The covered right renal artery was left covered.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition the device was returned to gore for evaluation.The device evaluation showed the device had been deployed off the catheter.A notch from the deployment line was seen at the leading olive stitch hole on one side.The deployment line was not returned for evaluation.The findings from the evaluation are consistent with the physician¿s observations.The cause for the device moving proximally during deployment could not be determined with the currently available information.The observation that the device appeared to not fully expand while it was being deployed was likely due to the deployment line had not yet fully unlaced from the leading olive and leading end of device.Addition h6: code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.Addition h6: code 4315.

• Brand Name: GORE EXCLUDERAAA 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: 11701612
• Report Number: 3013164176-2021-01157
• Device Sequence Number: 3646812
• Product Code: MIH
• UDI-Device Identifier: 00733132618781
• UDI-Public: 00733132618781
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 09/28/2023
• Device Model Number: PLA280300
• Device Catalogue Number: PLA280300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 04/06/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 04/21/2021
• Supplement Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 84 YR
• Patient Weight: 77