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

Model Number CXT261212

Device Problem Material Invagination (1336)

Patient Problem Aneurysm (1708)

Event Date 10/20/2021

Event Type  Death  

Event Description

On (b)(6) 2021, this patient underwent endovascular treatment of an abdominal aortic aneurysm and was implanted with gore® excluder® conformable aaa endoprostheses (excc).After gaining access via bilateral femoral cutdowns, sheaths were advanced into the mid and proximal infrarenal aorta.The excc was advanced thru a 16 french sheath and placed at the level of the renal arteries.Angiography was performed and the device was deployed without incident, however the contralateral gate was noted to be compressed.Cannulation of the gate was performed without difficulty and a pigtail was advanced and spun to confirm that the wire was in the body of the graft.A contralateral limb was then advanced after the sheath and dilator were placed into the gate of the trunk.The sheath was drawn back below the level of the left hypogastric artery and deployed.The trunk was then fully deployed and an extension limb, which was marked after doing an injection of contrast thru the sheath was place to the level of the right hypogastric artery.The proximal part of the trunk was ballooned with a coda balloon and kissing 12 mm pta balloons were used in the limbs.Then bilateral 10mm diameter luminexx¿ self-expanding stents were implanted in the external iliac arteries.At this time the patient¿s blood pressure was noted by anesthesia to be dropping.Angiography was performed and no leak was seen however a dissection of the left iliac artery (lia) distal to the graft was determined.A 13x10 gore® viabahn® endoprosthesis with heparin bioactive surface was implanted in the lia with intentional coverage of the hypogastric artery.Post placement of viabahn® the patient was transfused and the blood pressure improved.Approximately 5 minutes later the patient¿s blood pressure dropped again and the physician chose to open the patient¿s belly, the coda balloon was advanced to the level of the visceral vessels and inflated, which stabilized the blood pressure.Once exposure was done, a rupture of the aorta at the level of the limbs approximately 15-17 mm distally was determined.The patient was converted to open and an aortobifemoral bypass was performed.The patient tolerated the procedure in stable condition.It was reported that the physician noted that patient was not a good surgical candidate.Concerns noted post review of the films were the patient¿s short proximal aortic neck (10mm -12 mm in length) a small distal aorta (15mm -17 mm in diameter over a 3 cm length) and calcification of the access vessel coupled with the diameter of the access vessel bilaterally (5.5mm -6 mm diameter) bilaterally.After all concerns were discussed with the patient the physician chose to proceed with evar.The dissection was thought to have been due to the calcification throughout the patient¿s access vessels and the rupture of the distal aorta is believed to have been caused by angioplasty with the kissing balloons.On (b)(6) 2021, it was reported that the patient expired.The physician stated the cause of death was multisystem organ failure.

Manufacturer Narrative

Patient medical history includes but is not limited to: cad.Concomitant medical products: patient medications include but are not limited to: unspecified medications for treatment of hypertension and cad.

Manufacturer Narrative

Images were provided to gore for evaluation and showed the following: images provided for evaluation are pre-implant cta.Diameter just distal to the left renal measures ~ 19 mm.Diameter ~ 5 mm distal to the left renal measures ~ 17 mm.Diameter ~ 10 mm distal to the left renal measures ~ 16 mm.Diameter ~ 15 mm distal to the left renal measures ~ 30 mm.There appears to be a reverse taper present at the proximal neck.There does not appear to be 15 mm of aortic neck available.Diameters in the 3.3 cm proximal to the aortic bifurcation range from 9.6 mm ¿ 16.6 mm.Distal waist diameters measure < 18 mm.Diameters in the rci range from 5.4 mm ¿ 7.2 mm (just proximal to the riia).Diameters in the rei range from 5.1 mm ¿ 6.4 mm.Diameters in the lci range from 7.1 mm ¿ 8.3 mm.Diameters in the lei range from 5.3 mm ¿ 6.4 mm.

Manufacturer Narrative

H10/11: corrected g4 pma/510k number.

Event Description

On (b)(6) 2021, it was reported that the patient expired.The physician stated the cause of death was multisystem organ failure.The physician stated the multisystem organ failure could have been caused by the emergent conversion due to the rupture of the aorta when ballooning the two limbs down close to the aortic bifurcation.She ended up having issues due to prolonged anesthesia of almost 8 1/2 to 9 hours.As well the patient was not an ideal surgical candidate in the first place and that was the reason for attempting the endovascular repair.

Manufacturer Narrative

G3, h6: corrected information.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS
• Type of Device: 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12800769
• MDR Text Key: 283512735
• Report Number: 3007284313-2021-01654
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132651023
• UDI-Public: 00733132651023
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/03/2022

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?: Yes
• Device Expiration Date: 04/14/2023
• Device Model Number: CXT261212
• Device Catalogue Number: CXT261212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/21/2021
• Initial Date FDA Received: 11/11/2021
• Supplement Dates Manufacturer Received: 10/21/2021; 03/29/2022; 03/29/2022; 10/20/2021
• Supplement Dates FDA Received: 11/12/2021; 03/29/2022; 06/02/2022; 06/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Hospitalization; Death; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 74 KG