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

Catalog Number RLT261416

Device Problems Fracture (1260); Material Invagination (1336)

Patient Problem No Code Available (3191)

Event Date 03/13/2018

Event Type  Injury  

Manufacturer Narrative

Udi for gore® excluder® trunk-ipsilateral leg component rlt261416: (b)(4).Udi for gore® excluder® iliac extender component pll161407:(b)(4).Udi for gore® excluder® contralateral leg component plc201400: (b)(4).Udi for gore® excluder® contralateral leg component plc231000: (b)(4).The review of the manufacturing records verified that the lots involved in this event met all pre-release specifications.(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2018, this patient underwent endovascular treatment for an abdominal aortic aneurysm (aaa) and was treated with gore® excluder® aaa endoprostheses.After all endoprostheses had been implanted, final imaging showed a good overall result apart from a mínimal lack of wall apposition involving the proximal portion of the trunk.No obvious reason for the lacking apposition was identified and neither anatomical issues nor a calcified aortic neck was reported.However, re-ballooning of the trunk's proximal end was not performed.On (b)(6) 2018, the patient presented with acute abdominal discomfort and pain in both of his legs.Follow-up ct imaging revealed that above the flow divider, the trunk had severely invaginated and appeared in the shape of a half moon.On (b)(6) 2018, and after initially intending to re-balloon the trunk, the physician reconsidered and elected to explant all devices to prevent potential future thrombotic device occlusion.The patient tolerated the procedure.

Manufacturer Narrative

Post-operative computed tomography angiography (cta) images dated march 13, 2018, were returned to gore and an imaging evaluation was performed.The length from the left lowest renal to the proximal end of the device appears to measure approximately 6 mm.Diameters in the first 15 mm of the aortic neck, distal to the left lowest renal measure approximately 23 mm.The proximal end of the device appears to be folding in and is not apposed to the aortic wall.The length from the left lowest renal to the flow divider appears to measure approximately 49 mm.The proximal end of the device appears to be folding in and is not apposed to the aortic wall at the proximal end of the device.There appears to be contrast outside of the implanted device.There appears to be contrast distal to the implanted device bilaterally.Additionally, the devices were returned to w.L.Gore & associates for investigation.Submitted unfixed were four gore® excluder® aaa endoprostheses; one trunk ¿ ipsilateral leg endoprosthesis (trunk, rlt261416/17412047), two contralateral leg endoprostheses (cl-1 & cl-2, plc201400/17418244 & plc231000/17495483), and one iliac extender endoprosthesis (ie, pll161407/17188668).The devices arrived in an overlapping configuration.The cl-1 was primarily contained in the length of ipsilateral leg of the trunk.The proximal end of the ie was contained in the distal aspect of the contralateral gate of trunk.Cl-2 was separated from the endoprosthesis system prior to arrival.The lumina of the devices were widely patent.The luminal and abluminal device surfaces were generally devoid of tissue except for scattered plaques of friable red/brown material consistent with dried blood.The proximal trunk was circular and expanded.At the ipsilateral leg region of the trunk, (distal to the bifurcation and proximal to cl-1 overlapping region), a flaccid, depressed, non-circular region of the stent was present.Along the perimeters of this region multiple wire discontinuities were noted in a linear fashion at consecutive apices.One additional wire fracture was noted on the body of the trunk at an apex.Histopathological examination was not performed due to the paucity of adherent tissue.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion the device was examined for material disruptions with the aid of a stereomicroscope and sent for metallurgical analysis.The examined wire discontinuities (from trunk) exhibited characteristics consistent with fracture due to cyclic fatigue loading.Confirmed via ct imaging (from mar 13, 2018) was invagination of the proximal trunk, half-moon shaped, and an elliptic region of the ipsilateral leg (distal to the trunk bifurcation and proximal to cl-1) which extended distally through the ipsilateral leg to approximately 68 mm were it began to expand.The images correspond with the flaccid region of the explanted device.The wire fractures aligned with the pattern of the invagination and elliptical presentation of the graft, however the time point of the fractures in relation to the graft invagination could not be determined.

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7410946
• MDR Text Key: 105415145
• Report Number: 3007284313-2018-00119
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2020
• Device Catalogue Number: RLT261416
• Device Lot Number: 17412047
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/10/2018
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/21/2019; 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 75 YR
• Patient Weight: 85