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

Model Number	PXT311415
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Intra- and postprocedural dicom angiography imaging series have been request.Some imaging series were provided for evaluation.The device remains implanted in the patient.Therefore a device evaluation could not be performed.A review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.The imaging evaluation summary stated the following: images provided are post-implant, arterial phase only, cta dated (b)(6) 2021.Unable to confirm endoeleak with available image set, non-contrast images not provided for evaluation.Unable to confirm aneurysmal growth with only one time-point to evaluate.There appears to be bilateral accessory renals present.There appears to be patent lumbar arteries present.There appears to be a lack of wall apposition at the distal end of the implanted device within the right common iliac artery.
Event or Problem Description
On (b)(6) 2009, the patient presented with an aortic aneurysm which was treated with a gore® excluder® aaa endoprosthesis using pxt311415 (trunk and ipsilateral leg), pxl161007 (iliac extender) and pxc121000 (contralateral leg).On (b)(6) 2021, the patient presented at the hospital with growth of the aneurysmal sac.It remains unclear what caused the growth.Reportedly, computed tomography angiography imaging demonstrates a small cloud of contrast just below the infrarenal neck.On (b)(6) 2021, a reintervention was performed to treat the sac growth.The physicians performed multiple angiography imaging to figure out where the endoleak came from, but it was not visible.Reportedly, there was 4 mm seal to gain in the proximal neck, so an gore® excluder® aaa endoprosthesis pla360400 was placed below the renal arteries.In the left and right common iliac artery was seal to gain as well, so on the right side a gore® excluder® aaa endoprosthesis plc141000 was implanted and on the left side a plc161200 was implanted.They stated, that final angiography imaging showed a good result.Reportedly, the physicians finally suspected a patient position enhanced endoleak, because the contralateral leg on the left side didn¿t had much seal distally.They suspected, that maybe if the patient was sitting or in another position, it might be possible that some blood could still fill the aneurysmal sac because of lack of distal sealing.

• 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: 11757356
• Report Number: 2017233-2021-01935
• Device Sequence Number: 19777698
• Product Code: MIH
• UDI-Device Identifier: 00733132610341
• UDI-Public: 00733132610341
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/30/2021

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: 07/31/2011
• Device Model Number: PXT311415
• Device Catalogue Number: PXT311415
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 73 YR