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

Model Number PLC271000

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Aneurysm (1708); Unspecified Vascular Problem (4441)

Event Date 09/28/2021

Event Type  Injury  

Event Description

It was reported that a patient was treated for an aortic pathology with a gore® excluder® aaa endoprosthesis and a gore® excluder® iliac branch endoprosthesis on (b)(6) 2016.On (b)(6) 2022, the underwent a coil embolization procedure and implantation of a flared limb.The patient had previously presented with dilation of the central iliac artery before it was determined a reintervention was needed.

Manufacturer Narrative

Patient information has been requested but not yet provided.A manufacturer placeholder number is used as the patient id.Concomitant medical products: gore® excluder® iliac branch endoprosthesis iliac branch, ceb231010a, sn (b)(4); gore® excluder® iliac branch endoprosthesis internal iliac, hgb161207, sn (b)(4); gore® excluder® aaa endoprosthesis trunk - ipsilateral leg, rlt311413, sn (b)(4); gore® excluder® aaa endoprosthesis contralateral leg, plc271000, sn (b)(4).The name of the physician has been requested but not yet provided.Device remains implanted.Product history review is still in progress.Additional information regarding the complaint has been requested but not yet provided.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

It was reported that a patient was treated for an aortic pathology with a gore® excluder® iliac branch endoprosthesis and a gore® excluder® aaa endoprosthesis on (b)(6) 2016.The patient was examined on (b)(6) 2022.No reintervention was planned as a result of these examinations.On (b)(6) 2021, it was decided that the patient required a reintervention to treat dilation of the left common iliac artery.On (b)(6) 2022, the patient underwent a coil embolization procedure and implantation of a flared limb.The physician believes the dilation was due to disease progression.No aneurysm growth was observed.No patient imaging is available.The device remains implanted.

Manufacturer Narrative

Corrected event date.

Event Description

It was reported that a patient was treated for an aortic pathology with a gore® excluder® iliac branch endoprosthesis and a gore® excluder® aaa endoprosthesis on (b)(6) 2016.On (b)(6) 2022, the patient underwent a coil embolization procedure and implantation of a flared limb after presenting with dilation of the left common iliac artery.The physician believes the dilation was due to disease progression.No aneurysm growth was observed.No patient imaging is available.The device remains implanted.

Manufacturer Narrative

A review of the manufacturing records indicated the lot met pre-release specifications.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15669623
• MDR Text Key: 302400879
• Report Number: 2953161-2022-01153
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618538
• UDI-Public: 00733132618538
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/09/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2019
• Device Model Number: PLC271000
• Device Catalogue Number: PLC271000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2022
• Initial Date FDA Received: 10/25/2022
• Supplement Dates Manufacturer Received: 06/30/2023; 08/01/2023; 08/09/2023
• Supplement Dates FDA Received: 06/30/2023; 08/01/2023; 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SEE H10
• Patient Outcome(s): Other