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	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The medical device remains implanted.A review of the manufacturing records indicated the lot met pre-release specifications.Dicom imaging series were requested for evaluation but they could not be shared with gore.
Event or Problem Description
On (b)(6) 2019, the patient presented with an aortic aneurysm with was endovascularly treated with a gore® excluder® aaa endoprosthesis system.In total six devices have been implanted.On unknown date the patient presented with a type 1b endoleak which occurred at the distal end of the contralateral leg of the gore® excluder® aaa endoprosthesis (plc181200).On (b)(6) 2021, during an endovascular reintervention, the type 1b endoleak was treated by extending the contralateral leg into the common internal artery with two gore® excluder® aaa endoprostheses (pll161407 and plc231200).

• 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: 11351657
• Report Number: 3013164176-2021-01122
• Device Sequence Number: 2564272
• Product Code: MIH
• UDI-Device Identifier: 00733132618736
• UDI-Public: 00733132618736
• 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: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/19/2021

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: 10/23/2021
• Device Model Number: PLC181200
• Device Catalogue Number: PLC181200
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/19/2021
• 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