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

Model Number HGB161407A

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

Patient weight: asked but unavailable.Other relevant history, including preexisting medical conditions: asked but unavailable.Concomitant medical products and therapy dates: asked but unavailable.Type of investigation: code b15 - the device was discarded at the facility.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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

On (b)(6) 2023, the patient underwent endovascular treatment using gore® excluder® iliac branch endoprostheses.It was reported that, while attempting to deliver the hgb161407 internal iliac component, resistance was encountered and it was observed that the wires were wrapped distally.Upon removing the undeployed device out of the sheath to reposition the wires, the device separated from the catheter within the introducer sheath at the level of the trailing olive.This was reportedly due to the severe wire wrap around the device.The entire introducer sheath was removed with the device inside with no clinical sequelae to the patient.A new dsf1245 gore® dryseal flex introducer sheath was inserted, the internal iliac was rewired, a new device was used, and the procedure was completed without incident.The sheath with detached device was disposed of following the case.There were no further reported issues.

Manufacturer Narrative

Event description: additional information added.Investigation findings for testing of actual/suspected device: code c21 remains unchanged investigation conclusions: code d16 remains unchanged d.9.Device returned to manufacturer updated type of investigation: code b15 updated to code b01.

Event Description

The treatment on march 10, 2023, was for an iliac artery aneurysm the constrained device broke away from the delivery catheter at the trailing olive.

Manufacturer Narrative

H.6.Investigations findings for testing of actual/suspected device: code 19 - the device and introducer sheath were returned for evaluation and the device evaluation showed the following: the leading end of the catheter had separated from the catheter body at the trailing olive.The catheter was returned with blood indicating use of the device in the patient.The trailing olive end was intact and not ripped or torn.There was evidence of indentations from the guidewire lumen braid indicating that the leading end of the catheter had been bonded at the trailing olive.While attempting to advance a guidewire through the introducer sheath, there was an obstruction in the sheath.The cause of the obstruction could not be observed.However, the complaint detail describes that the leading end of the catheter and stent graft had separated from the remainder of the catheter in the introducer sheath.It is likely that the obstruction in the introducer sheath is the leading end of the catheter and stent graft as described in the complaint detail.The findings from the evaluation are consistent with the reported observations.The likely cause for the reported observation that resistance was encountered during delivering (advancing) the device, and the observed wire wrap could not be determined with the available information.The cause for the device separation from the catheter within the introducer sheath could not be determined with the currently available information.However, the attempt to remove the undeployed device through the introducer sheath and the reported severe wire wrap around the device may have contributed to the event.H.6.Conclusions code d1002 added.H.6.Conclusions code d12 added.The gore® excluder® iliac branch endoprosthesis instructions for use (ifu) states, "do not attempt to withdraw any undeployed endoprosthesis through the introducer sheaths.The sheath and undeployed device catheter must be removed together.Catheter breakage or separation or premature deployment have occurred and may result in potential patient harms." additionally, the ifu states that wire wrap can lead to catheter breakage due to interactions between the throughwire and lliac branch component (ibc) delivery catheter.H.6.Investigation findings for testing of actual/suspected device: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d15.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16705357
• MDR Text Key: 312945098
• Report Number: 3013164176-2023-01660
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132635337
• UDI-Public: 00733132635337
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/11/2023

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 Model Number: HGB161407A
• Device Catalogue Number: HGB161407A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/09/2023
• Supplement Dates Manufacturer Received: 04/17/2023; 07/17/2023
• Supplement Dates FDA Received: 05/16/2023; 08/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2023
• 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
• Patient Age: 64 YR
• Patient Sex: Male