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

Catalog Number HGB161407

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/09/2022

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.Engineering evaluation could not be performed as the endoprosthesis remains implanted and the introducer sheath is not available for return.A review of the manufacturing records indicated the lot met pre-release specifications.

Event Description

It was reported that a patient presented with abdominal aortic aneurysm that has been treated with gore® excluder® aaa endoprostheses on (b)(6) 2022.During the procedure, the leading end became hooked on the lock before being pulled out.The olive tore off and was not able to be removed.It is now in the side branch of the left internal illiac artery.The patient tolerated the procedure.

Event Description

It was reported that a patient presented with abdominal aortic aneurysm that has been treated with gore® excluder® aaa endoprostheses on (b)(6) 2022.During the procedure, the leading end became hooked on the lock before being pulled out.The olive tore off and was not able to be removed.It is now in the side branch of the left internal illiac artery.The patient tolerated the procedure.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: engineering evaluation could not be performed as the endoprosthesis remains implanted and the introducer sheath is not available for return.H6: a review of the manufacturing records indicated the lot met pre-release specifications.The device was not returned for evaluation.The evaluation was completed using a picture provided form the field.The picture evaluation showed the following: o the leading olive had separated from the rest of the catheter.A picture of the separated leading olive was not provided.O the device was deployed off the catheter.O there was olive material transfer seen at the bonding site of the leading olive on the catheter polyimide guidewire lumen indicating the leading olive had been bonded to the catheter.The excluder iliac branch endoprosthesis instructions for use (ifu) clearly states: o do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter breakage or separation and reintervention resulting in potential patient harms.O catheter leading end separation or breakage and related potential patient harms have occurred.If catheter separation occurs, use best medical judgment to determine the appropriate course of action for the patient.Effective removal of the catheter component has been reported through both surgical (e.G.Cut down) and endovascular techniques (e.G.Snaring, sheath removal).The findings from the evaluation are consistent with the physician¿s observations for leading olive separation.The cause for the leading olive separation could not be determined with the currently available information.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.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: engineering evaluation could not be performed as the endoprosthesis remains implanted and the introducer sheath is not available for return.H6: a review of the manufacturing records indicated the lot met pre-release specifications.The findings from the evaluation are consistent with the physician¿s observations for leading olive separation.The cause for the leading olive separation could not be determined with the currently available information.The excluder iliac branch endoprosthesis instructions for use (ifu) clearly states: do not continue to withdraw the delivery catheter if resistance is felt during removal through the introducer sheath.Forcibly withdrawing the delivery catheter through the introducer sheath when resistance is encountered has resulted in adverse events including catheter breakage or separation and reintervention resulting in potential patient harms.- when withdrawing the device delivery system through the introducer sheath, verify all catheter components are intact.- catheter leading end separation or breakage and related potential patient harms have occurred.If catheter separation occurs, use best medical judgment to determine the appropriate course of action for the patient.Effective removal of the catheter component has been reported through both surgical (e.G.Cut down) and endovascular techniques (e.G.Snaring, sheath removal).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.

Manufacturer Narrative

Contact office - manufacturing site corrected from previous report.Site number: (b)(4).

• 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: tom hormby ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13929222
• MDR Text Key: 288030590
• Report Number: 3007284313-2022-01839
• Device Sequence Number: 1
• Product Code: MIH
• 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,Followup
• Report Date: 08/30/2022

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 Catalogue Number: HGB161407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2022
• Initial Date FDA Received: 03/28/2022
• Supplement Dates Manufacturer Received: 03/11/2022; 08/18/2022; 08/30/2022
• Supplement Dates FDA Received: 04/22/2022; 08/18/2022; 08/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• Is the Device Single Use?: No
• 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; GORE® DRYSEAL FLEX INTRODUCER SHEATH
• Patient Outcome(s): Other