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

Model Number	PLC181200
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Occlusion (1984)
Date of Event	11/12/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2020, this patient presented to the hospital with a ruptured 10 cm abdominal aortic aneurysm.The patient had a 90° proximal aortic neck.A gore® excluder® aaa endoprosthesis trunk-ipsilateral leg component was implanted successfully along with the limbs on the left side.An extension was needed on the right side.The c-arm in the room used for imaging overheated, so another c-arm was brought in the operating room.However, that c-arm was an older unit, and had poor image quality.Therefore, the contralateral leg was deployed in the incorrect position and was deployed 4 cm lower than intended and unintentionally covered the right hypogastric artery.As the left hypogastric artery had good perfusion, the physician decided to leave it as is.The patient was left in icu to recover for 6 hours, but as he was being transferred to the recovery floor, he coded.After his vitals were recovered he was taken back into the catheter lab, where imaging showed that the contralateral leg in the right limb had become dislodged and moved distally.Therefore, an additional contralateral leg was implanted on the right side to bridge the previously implanted contralateral leg and the trunk-ipsilateral leg component.
Additional Manufacturer Narrative
Corrected data: g1: manufacturing site and address.

• 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: 10987334
• Report Number: 3007284313-2020-01190
• Device Sequence Number: 19008612
• Product Code: MIH
• UDI-Device Identifier: 00733132618736
• UDI-Public: 00733132618736
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 06/04/2023
• Device Model Number: PLC181200
• Device Catalogue Number: PLC181200
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/10/2020
• Supplement Report FDA Received Date: 06/09/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 64 YR
• Patient Weight: 113