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

Catalog Number RLT351416

Device Problems Complete Blockage (1094); Material Separation (1562); Premature Separation (4045)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/31/2024

Event Type  Injury  

Manufacturer Narrative

The following investigations are planned: product history records (b14), engineering evaluation of the delivery system and explanted device (currently in transit) (b01), imaging evaluation (b15).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 to gore that a gore® excluder® aaa endoprosthesis was intended to be used for an infra renal aneurysm repair.The device was placed via the right side access through a 18fr gore® dryseal flex introducer sheath.Initial deployment was done above the intended landing zone in order to cannulate the contra lateral limb.After cannulation, the proximal part of the device was re-constrained and pulled down to the intended landing zone.Before landing zone was reached the proximal part of the device suddenly opened up again while the deployment knob was still in its constrained position.The sudden release of the constraining was reported to be faster than a normal rotation of the constraining mechanism.It is however not confirmed if the physician felt any line breakage.The physician tried to pull the device slightly down in order to get to landing zone.The device dislodged and deployed from the delivery system without the physician completing the deployment steps or access the line hatch.The delivery catheter was removed and the patient was converted to open surgery and the device was explanted as all renal arteries and sma was covered.The patient has recovered from the procedure.

Manufacturer Narrative

As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.The device evaluation showed the following: the delivery catheter was received with the constraining mechanism attached, with the guide nut in the fully constrained position.The constraining loop, lock pin, and second deployment line were observed to be coming out of the appropriate lumens at the leading end of the device, indicating that the endoprosthesis had prematurely dislodged from the delivery catheter.The leading end of the constraining loop was visually inspected.The eyelet of the constraining loop was fully intact with no obvious damage.The lock pin was visually inspected.The leading end of the lock pin appeared to have a clean cut and was free from damage and kinks.No abnormalities were noticed.The leading olive was visually inspected.The leading olive did not show signs of deformation.The hole of the leading olive, where the lock pin is inserted, was free from damage.No abnormalities were noticed.The screw assembly was inspected.The screw knob was able to be turned clockwise and counterclockwise and the guide nut moved in the appropriate respective directions.The endoprosthesis was visually inspected.The ipsilateral leg of the endoprosthesis was twisted and the stent wire was broken at one point, which caused a section of the stent wire to separate from the graft.The imaging evaluation concluded the following: the first image shows the proximal end of a gore® excluder® endoprosthesis with the proximal end not fully expanded.It could not be confirmed what visceral vessels are patent with the tiny image provided and lack of anatomical structures visualized.Image is suggestive that the proximal device may be proximal to a renal artery.The instructions for use (ifu) states the following: do not cover significant renal or mesenteric arteries with the endoprosthesis.Vessel occlusion may occur.Based on the findings of this evaluation, the physician¿s observation that ¿before landing zone was reached the proximal part of the device suddenly opened up again while the deployment knob was still in its constrained position¿ could not be confirmed.Based on the findings of this evaluation, the physician¿s observation that ¿the device dislodged and deployed from the delivery system without the physician completing the deployment steps or access the line hatch¿ could be confirmed.The likely cause for the endoprosthesis suddenly unconstraining and for the endoprosthesis becoming dislodged from the delivery catheter could not be determined with the available information.In summary: the observations of the provided device photos, clinical images, and returned device are consistent with the reported failure mode of premature deployment.The constraining mechanism (in the fully constrained position) and second deployment knob were still attached to the delivery handle, and the endoprosthesis was removed.Additionally, the lock pin, constraining look, and secondary deployment line were observed out of the appropriate lumens at the leading end of the delivery catheter indicating the endoprosthesis had deployed prematurely.The reported failure mode that the device spontaneously unconstrained could not be independently confirmed, but it is likely related to the premature deployment.The root cause of the device spontaneously unconstraining and premature deployment could not be established with the available information.In addition, it was reported that the device was initially deployed above the intended landing zone to aid in cannulation.A note is included in the instructions for use (ifu) cautioning against covering significant renal or mesenteric arteries.No correlation between the initial deployment location and the reported failure mode can be determined.B1: product problem (e.G., defects/malfunctions) is additionally selected.H6: replaced a140901 with a0413.Add g04044.Updated investigation findings code to c19, code c21 is no longer applicable.Updated investigation conclusions code to d15 and d12.Code d16 is no longer applicable.

Manufacturer Narrative

The endoprosthesis was visually inspected.The ipsilateral leg of the endoprosthesis was twisted and the stent wire was broken at one point, which caused a section of the stent wire to separate from the graft.This damage likely occurred during the reported explant of the endoprosthesis.Therefore, in h6, code a0413 was inadvertently entered and should be removed.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18674602
• MDR Text Key: 334949285
• Report Number: 3007284313-2024-03044
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618484
• UDI-Public: 00733132618484
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/21/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RLT351416
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 05/13/2024; 05/16/2024
• Supplement Dates FDA Received: 05/16/2024; 05/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2021
• 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: SUPRACORE 300, DSF1833
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male