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

Catalog Number PLC271200

Device Problems Positioning Failure (1158); Premature Activation (1484)

Patient Problems Foreign Body Embolism (4439); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/17/2023

Event Type  Injury  

Manufacturer Narrative

A1: the gore reference number was used as the patient identifier.D10 concomittant devices: gore® excluder® iliac branch endoprosthesis (catalog ceb231410, sn (b)(6)).Gore® excluder® conformable aaa endoprosthesis with active control system (catalog cxt241412e, sn (b)(6)).Gore® dryseal flex introducer sheath (catalog dsf1633, sn (b)(6)).H6-b13: a request was sent to the physician to further clarify the event and to provide images of the case.The answer was captured in the event description.H6-b14: a review of the manufacturing records indicated the lot met pre-release specifications.H6-b15: one imaging dataset was shared with gore for evaluation.The imaging evaluation summary states the following: pre-implantation cta dated (b)(6) 2023.The lci is aneurysmal and the left iliac arteries are tortuous.The images provided do not allow for evaluation in relation to the reported complaint.H6-b17 and h3 other: the device remains implanted and the delivery system was discarded at the facility.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 the patient presented with an abdominal aortic aneurysm was treated with a gore® excluder® conformable aaa endoprosthesis with active control system and a gore® excluder® iliac branch endoprosthesis in the right common iliac artery.It was stated that the gore® excluder® iliac branch endoprosthesis (iliac branch component, ceb231410 device) and the gore® excluder® iliac branch endoprosthesis (internal iliac component, hgb161407 device) were implanted without any problems in the right common iliac artery via a gore® dryseal flex introducer sheath (dsf1633 sheath) placed in the right and a dsf1245 sheath in the left common iliac artery.Then the dsf1245 sheath was replaced with a dsf1833 sheath to successfully implant a gore® excluder® conformable aaa endoprosthesis with active control system (cxt241412e device).Then a gore® excluder® iliac branch endoprosthesis (contralateral leg endoprosthesis, pcl271200 device) was used as a bridging device.It was advanced through the dsf1633 sheath to the right common iliac artery.Reportedly very little push was needed to land exactly at the bifurcation of the ceb231410 device.It was reported that they started to deploy the proximal part of the pcl271200 device.Then they stopped pulling the deployment line for giving compression to the catheter to move the device little more proximal.At this stage the pcl271200 device further deployed unintentionally without pulling the deployment line.Reportedly the plc271200 device landed too far distally covering the internal iliac artery and having only 1-2 mm proximal overlap with the contralateral leg of the cxt241412e device.It was reported that they then continued to pull the deployment line very slowly and it felt like knots opening up.Eventually the deployment line was removed completely.To reposition the deployed device they tried to push the plc271200 device up by using the dsf1633 sheath without dilator, but the plc271200 device did not move.Due to the long procedure time of five hours it was decided to complete the intervention without revision.On (b)(6), 2023, it was reported to gore that the patient is doing good, and that neither buttock claudication nor ischemia has developed.

Manufacturer Narrative

B1: only "serious injury" is applicable.The available information reported in the complaint does not reasonably suggest a potential malfunction has occurred.

Manufacturer Narrative

B5: updated event description cause investigation and conclusion: additional information to the event and clinical imaging series for evaluation were requested from the physician.Provided information were captured in section 3.A review of the manufacturing records indicated the lot met pre-release specifications.One pre-implantation computed tomography angiography dated (b)(6) 2023 was shared with gore for evaluation.The images showed an aneurysmal left common iliac artery and left iliac arteries appeared to be very tortuous.However, the pre-implantation images provided did not allow for evaluation in relation to the reported incident.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, nor delivery system of the device was discarded at the facility, were returned for evaluation.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.No potential new or different reasonably foreseeable risks related to the device or its use were identified based on this event.Ongoing risk/benefit assessment affirms risk acceptability based on current performance.No corrective measures are needed as a result of this event.Gore will continue to monitor post-market data closely to ensure that the risk assessment remains accurate.No clinical images demonstrating reported unintentional deployment or mispositioning of the device were shared with gore for evaluation.It was reported that they deployed the proximal part of the device and then they stopped pulling the deployment line for giving compression to the catheter to reposition the device.This procedure step suggests that the device was not placed in the intended position initially when they started deployment indicating a potential reasonably foreseeable misuse.The instructions for use (ifu) for the appropriate region and time-period was reviewed with respect to the complaint details.The ifu states the following: contralateral leg endoprosthesis positioning and deployment "loosen the deployment knob.Confirm final device position.Deploy the contralateral leg endoprosthesis by using a steady, continuous pull of the deployment knob to release the endoprosthesis.Pull the deployment knob straight out from the catheter side-arm.Deployment initiates from the leading (aortic) end toward the trailing (iliac) end." warning: do not attempt to reposition the endoprosthesis after deployment has been initiated.Vessel damage or device misplacement may result.Potential device or procedure-related adverse events adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: improper component placement;.

Event Description

It was reported to gore, that the patient presented with an abdominal aortic aneurysm was treated with a gore® excluder® conformable aaa endoprosthesis with active control system and a gore® excluder® iliac branch endoprosthesis in the right common iliac artery.It was stated that the gore® excluder® iliac branch endoprosthesis (iliac branch component, ceb231410 device) and the gore® excluder® iliac branch endoprosthesis (internal iliac component, hgb161407 device) were implanted without any problems in the right common iliac artery via a gore® dryseal flex introducer sheath (dsf1633 sheath) placed in the right and a dsf1245 sheath in the left common iliac artery.Then the dsf1245 sheath was replaced with a dsf1833 sheath to successfully implant a gore® excluder® conformable aaa endoprosthesis with active control system (cxt241412e device).Then a gore® excluder® aaa endoprosthesis (contralateral leg endoprosthesis, plc271200 device) was used as a bridging device.It was advanced through the dsf1633 sheath to the right common iliac artery.Reportedly very little push was needed to land exactly at the bifurcation of the ceb231410 device.It was reported that they started to deploy the proximal part of the plc271200 device.Then they stopped pulling the deployment line for giving compression to the catheter to move the device little more proximal.At this stage the plc271200 device further deployed unintentionally without pulling the deployment line.The surgeon stated that he is not aware about any potential cause of the unintentional deployment.Reportedly the plc271200 device landed too far distally covering the internal iliac artery and having only 1-2 mm proximal overlap with the contralateral leg of the cxt241412e device.It was reported that they then continued to pull the deployment line very slowly and it felt like knots opening.Eventually the deployment line was removed completely.To reposition the deployed device, they tried to push the plc271200 device up by using the dsf1633 sheath without dilator, but the plc271200 device did not move.Due to the long procedure time of five hours, it was decided to complete the intervention without revision.On (b)(6) 2023, it was reported to gore that the patient is doing good, and that neither buttock claudication nor ischemia has developed due to the continued coverage of the internal iliac artery.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: sibylle staerk ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17443670
• MDR Text Key: 320232793
• Report Number: 3013164176-2023-01780
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618545
• UDI-Public: 00733132618545
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 11/28/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PLC271200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2023
• Initial Date FDA Received: 08/02/2023
• Supplement Dates Manufacturer Received: 11/17/2023; 11/17/2023
• Supplement Dates FDA Received: 11/20/2023; 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2023
• 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): Hospitalization
• Patient Age: 81 YR
• Patient Sex: Male