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

Model Number	CXA260005
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: tylenol, aspirin, bacillus coagulans/insulin, pletal, vitamin b12, cymbalta, zetia, glucosamine-chondroitin, cozaar, lopressor, remeron, tab-a-vite, prilosec, pravachol, ultram, and kenalog.
Event or Problem Description
On an unknown date, this patient was treated for an abdominal aortic aneurysm with a medtronic endurant device.It was reported the patient presented at atrium wake forest baptist health and that images (date and modality is unknown) revealed a proximal type i endoleak.The physician chose to treat the endoleak on (b)(6) 2022, with two gore® aortic extender endoprostheses.The field sales associate reported the following ¿the physician decided to place a 26mm conformable cuff (gore® aortic extender endoprosthesis) at the renal arteries and 28mm conformable cuff (gore® aortic extender endoprosthesis) out of the 26 and into the 28mm medtronic graft.A 16fr sheath (16fr gore® dryseal flex introducer sheath lot/serial number is unk) was inserted.The 26mm cuff was advanced through the 16fr sheath without incident, the physician removed the cuff (gore® aortic extender endoprosthesis) through the sheath and placed a pigtail catheter in to take another angio to mark the renal artery.The 26mm cuff (gore® aortic extender endoprosthesis) was re-advanced into position, the angulation wire was deployed completely, the cuff (gore® aortic extender endoprosthesis) was deployed in position, the angulation wire was retracted, the delivery system was removed.A 28mm cuff (gore® aortic extender endoprosthesis) was advanced and delivered without incident.The 28mm delivery system was removed without incident, the mob (gore® molding and occlusion balloon catheter) was advanced in position and the cuffs (gore® aortic extender endoprostheses) were ballooned.Upon removing the mob it was noticed that an olive tip was still on the wire.Both devices were checked, and it was discovered the olive tip was from the 26mm cuff (gore® aortic extender endoprosthesis) delivery system.The physician tried to snare the olive tip however the tip eventually became lodged in the sma (superior mesenteric artery).The patient was then prepped for open repair/removal of olive tip.The olive tip was successively removed.There is no evidence of a further type 1 endoleak.¿ the patient tolerated the procedure.Reportedly, the cause of the dislodged olive tip was due to, while removing the delivery catheter of the 26mm gore® aortic extender endoprosthesis, the delivery catheter got hung up on the 16fr gore® dryseal flex introducer sheath.There was a 60-degree bend in the aorta where the device and sheath became hung up.
Additional Manufacturer Narrative
Correction h3: device was returned to gore for an engineering evaluation on june 14, 2022.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14753984
• Report Number: 3007284313-2022-01976
• Device Sequence Number: 6153489
• Product Code: MIH
• UDI-Device Identifier: 00733132650941
• UDI-Public: 00733132650941
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2022

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: 04/13/2024
• Device Model Number: CXA260005
• Device Catalogue Number: CXA260005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/06/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 09/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 86 KG