MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	RMT281414
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medications: niacin, aspirin, tramadol, irbesartan, estradiol, and chlorthalidone.Additional devices implanted and/or related to this event: pxc141200/12454304: udi (b)(4).The review of the manufacturing paperwork verified that these lots met all pre-release specifications.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to occlusion of device or native vessel.
Event or Problem Description
On (b)(6) 2014, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.There were two non-gore® balloon expandable stents (brand is unknown) implanted distal to the gore® excluder® limbs, one on each side.It was reported that ultrasound images dated (b)(6) 2018, revealed a possible occluded limb on the left side of the implanted graft.On (b)(6) 2018, the physician reintervened and dilated the right limb with a 12mmx4cm balloon and did a right to left femoral popliteal bypass surgery.The occluded limb was occluded from the distal end of the stent on the left limb up to the flow divider of the rmt281414 device.The field sales associate recalls the pxc14122 device was on the left side also and occluded.The patient tolerated the reintervention.
Event or Problem Description
On (b)(6) 2014, the patient was implanted with a gore® excluder® aaa endoprostheses to treat an abdominal aortic aneurysm.There were two non-gore® balloon expandable stents (brand is unknown) implanted distal to the gore® excluder® limbs, one on each side.It was reported that ultrasound images dated on (b)(6) 2018, revealed a possible occluded limb on the left side of the implanted graft.On (b)(6) 2018, the physician reintervened and dilated the right limb with a 12mmx4cm balloon and did a fem-fem bypass surgery.The occluded limb was occluded from the distal end of the stent on the left limb up to the flow divider of the rmt281414 device.The field sales associate recalls the pxc14122 device was on the left side also and occluded.The patient tolerated the reintervention.
Additional Manufacturer Narrative
Correction event.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8248735
• Report Number: 2017233-2019-00034
• Device Sequence Number: 11332746
• Product Code: MIH
• UDI-Device Identifier: 00733132610716
• UDI-Public: 00733132610716
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/27/2019

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: 07/31/2016
• Device Catalogue Number: RMT281414
• Device Lot Number: 11735629
• 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: 01/15/2019
• Supplement Report FDA Received Date: 02/27/2019
• 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; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 64