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

Catalog Number HGB161007

Device Problems Leak/Splash (1354); Material Separation (1562); Component Missing (2306); Physical Resistance (2578)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that these lots met all pre-release specifications.(b)(4).The delivery catheter was discarded at the facility and not sent to gore for analysis.The investigation was completed using a photo of the broken device and feedback provided from the clinical specialist.The investigation photo of the broken device showed the delivery catheter was broken at the trailing olive.The device had been deployed off the catheter.The clinical specialist reported the leading end (the leading olive and gold braided polyimide) had pulled out of the trailing olive.The findings from the evaluation are consistent with the physician¿s observations.The cause for the damage to the delivery catheter could not be determined with the currently available information.This type of occurrence will continue to be monitored.The gore® excluder® iliac branch endoprosthesis instructions for use (ifu) clearly states: do not continue advancing and withdrawing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and assess the cause of resistance.Vessel or catheter damage may occur.Additional considerations for patient selection include but are not limited to a patient¿s anatomical suitability for endovascular repair.(b)(4).

Event Description

On (b)(6) 2018 a patient underwent treatment of a left internal iliac artery aneurysm with gore® excluder® aaa and iliac branch endoprostheses.The patient¿s anatomy, as reported, was tortuous and calcified.Bilateral cut-down access was obtained and the iliac branch component was placed at the aortic bifurcation and the first stage deployed.An 18fr gore® dryseal flex sheath was advanced over a through and through wire into the iliac branch component.A 12fr gore® dryseal flex sheath was inserted into the 18fr sheath and advanced beside the through and through wire into the contralateral gate of the iliac branch component.The internal iliac artery was cannulated, and following multiple attempts to position the device successfully, the internal iliac component was advanced over an amplatz wire over a tight curve into position.As reported, the device was deployed with forward pressure to ensure clearance for the contralateral leg component.Upon removal of the internal iliac component delivery catheter through the 12fr sheath, resistance was encountered.When the delivery catheter was withdrawn from the patient, the proximal olive tip and gold portion were noted to be missing.Multiple attempts to retrieve the olive tip with snares were made until finally the detached olive tip was retrieved via a talon bronchoscopy forceps.The remainder of the procedural steps were completed with successful exclusion of the aneurysm.A slight type ii endoleak from lumbar arteries (l3-4) was observed, but not treated.No aneurysm enlargement was identified.According to the physician, the patient¿s anatomy was outside the ifu and the physician believed this was the cause of the olive separation.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7626466
• MDR Text Key: 112447270
• Report Number: 3013164176-2018-00053
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Report Date: 05/29/2018

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: 03/27/2021
• Device Catalogue Number: HGB161007
• Device Lot Number: 17949181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2018
• 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: 71 YR