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

Model Number RLT281414

Device Problems Material Invagination (1336); Material Deformation (2976)

Patient Problems Numbness (2415); Obstruction/Occlusion (2422); Diminished Pulse Pressure (2606)

Event Date 08/15/2022

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.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 on (b)(6) 2022, a patient was treated with an gore® excluder® aaa endoprosthesis.On (b)(6) 2022, the patient presented with back pain and no pulse or feeling in the legs.The patient received a ct scan which showed that the endograft was occluded and had collapses in the aortic neck.The physician canalized the occluded stent graft and then dilated with a gore® molding and occlusion balloon.The physician also removed thrombus.The patient tolerated the reintervention but is still presenting with neurological symptoms in the legs.

Manufacturer Narrative

According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include but are not limited to arterial thrombosis and/or device/native vessel obstruction and, or occlusion.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.The imaging evaluation performed by a clinical imaging specialist shows findings consistent with the description summary: one set of post-implantation cta imaging is available for evaluation.Anonymized name and no date or demographics on the imaging.3d images show contrast outside the proximal end of the implanted device.Available axial imaging shows: confirmation of compression of the trunk portion of the device.Occlusion throughout the implanted devices consisting of the trunk ipsilateral leg and contralateral leg that extend into the rci and the contralateral leg that extends into the lci.Blood flow appears to reconstitute bilaterally distal to the end of the limbs in both the internal and external iliac arteries.There also appears to be isolated areas of thrombus in the right and left external iliac arteries and a possible dissection present in the lei.Portions of the lei appear to be partially occluded.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15442961
• MDR Text Key: 300120880
• Report Number: 3007284313-2022-02117
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132622535
• UDI-Public: 00733132622535
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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
• Report Date: 06/02/2023

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 Model Number: RLT281414
• Device Catalogue Number: RLT281414
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/19/2022
• Initial Date FDA Received: 09/17/2022
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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: GORE® DRYSEAL FLEX INTRODUCER SHEATH - DSF1233.GO.
• Patient Outcome(s): Other
• Patient Age: 65 YR