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

Model Number	PLC181000
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4): a review of the manufacturing records indicated the lot met pre-release specifications.(b)(4): the device is not accessible for investigation because it remains implanted.(b)(4): dicom imaging series have been requested for evaluation.Answer pending.
Event or Problem Description
On (b)(6) 2020, the patient presented with an abdominal aortic aneurysm which was treated with gore® excluder® aaa endoprostheses.To exclude the aneurysm the following devices were used: right side: cxt231412e (sn (b)(4) and plc181000 (sn (b)(4) left side: plc231200 (sn (b)(4) and plc231000 (sn (b)(4) on completion angiographic imaging of the implant procedure it was undetermined whether there was an endoleak type ib or type ii on the right side.On (b)(6) 2020, a computed tomography scan was done which proved inconclusive.On (b)(6) 2020, a second computed tomography scan was done which also proved inconclusive.On (b)(6) 2020, a third computed tomography scan was done at which point it was concluded it was an endoleak type ib and to perform an endovascular reintervention to extend with a device of larger diameter.There has been no sac expansion reported.The physician has said that the reason for the endoleak was an undersizing issue: initially the right limb plc181000 was undersized.A smaller diameter plc device was used than what actually should have been used.Reportedly, the plan is to embolize the right internal iliac artery and extend the right plc181000 limb into the right external iliac with a pll161007.The reintervention was scheduled for (b)(6) 2020.
Additional Manufacturer Narrative
H6-code 213: dicom imaging series were provided for investigation.The imaging evaluation summary states the following: there appears to be non-circumferential, significant ca+ within the r common iliac artery.There appears to be > 3 cm contiguous seal zone within the r common iliac artery.As mentioned in the description, an 18 mm device is outside of ifu but using such a device would appear to provide a >4 cm contiguous seal zone.

• 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: 10573306
• Report Number: 3013164176-2020-01045
• Device Sequence Number: 11083300
• Product Code: MIH
• UDI-Device Identifier: 00733132618743
• UDI-Public: 00733132618743
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 12/08/2020

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: 09/23/2022
• Device Model Number: PLC181000
• Device Catalogue Number: PLC181000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2020
• Supplement Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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: 82 YR