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

Model Number	PLA280300
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	01/21/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Concomitant medical devices: patient medications include but are not limited to: norvasc, cozaar, ativan, lipitor, prilosec, k-dur, klor-con, vitamin d, tylenol.Pma/510(k) #k172567.(b)(4).
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for an enlarging 5.5cm abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.It was reported that post deployment of the devices when performing completion angiography using a gore® molding & occlusion balloon (mob) the aorta was ruptured at the origin of the left renal artery caused by suspected over inflation of the balloon.The patient was converted to open repair.
Event or Problem Description
On (b)(6) 2020, this patient underwent endovascular treatment for an enlarging 5.5cm abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprostheses.It was reported that post deployment of the devices a proximal type i endoleak was seen and a gore® aortic extender component was placed proximally.During angioplasty of the aortic extender component using a gore® molding & occlusion balloon (mob), increased extravasation was seen and angiography determined a rupture at the origin of the left renal artery due to suspected over inflation of the balloon.Reportedly due to the patient's short angulated neck coupled with calcification in the aortic neck; good seal was unable to be achieved.The physician converted to open repair wherein grafts were sewn in to reline the devices.Massive transfusion protocol was initiated for the patient who was transfused with 11 litres.The procedure was concluded with an "open" close for the patient, with a plan was to reintervene the next day and perform an ax femoral bypass.On (b)(6) 2020, the patient expired.The cause of death was not available.
Additional Manufacturer Narrative
B5,b6: additional/corrected information.G.5: p020004.G9: please note that this event was reported in medwatch #3007284313-2020-00014.Details of the event required a separate medwatch submission for the aortic extender component; as such this medwatch is being submitted.H6: code 213- a review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.H.6.Code 22 - according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to: endoleak, bleeding, surgical conversion, death.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (LOW PROFILE)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9618820
• Report Number: 3013164176-2020-00007
• Device Sequence Number: 13578858
• Product Code: MIH
• UDI-Device Identifier: 00733132618781
• UDI-Public: 00733132618781
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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): 02/04/2020

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: 07/15/2022
• Device Model Number: PLA280300
• Device Catalogue Number: PLA280300
• Device Lot Number: 20848510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 02/12/2020
• 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: Death; Hospitalization; Other; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 69