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

Catalog Number PXC121200

Device Problems Premature Activation (1484); Retraction Problem (1536); Physical Resistance (2578)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/29/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, the patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.It was reported that the sheath was not positioned into the contralateral gate and the physician wanted to reposition the gore® dryseal sheath ((b)(4)) higher and decided to withdraw the undeployed contralateral leg component ((b)(4)) back into the sheath.It was reported that during withdrawal of the device back into the sheath, the physician felt some resistance.The physician continued to withdraw the device, and it was noted that the device partially deployed inside and outside the sheath.The sheath was pulled back and the completely opened device was deployed too far below the intended position unintentionally covering the internal iliac artery.Additionally, the physician noticed that the leading olive and the proximal part of the delivery catheter were broken and attached to the stiff wire.The physician was able to remove them from the patient.It was reported that the catheter was not torqued and there were no anatomical restrictions noted during the procedure that may have caused or contributed to the event.The physician used another contralateral leg component as a ¿bridge¿ to complete the procedure.No further adverse events have been reported.The patient tolerated the procedure.

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.The device was sent to gore for investigation.Further information will be provided.

Manufacturer Narrative

The gore® excluder® aaa endoprosthesis contralateral leg component was returned to gore for analysis.The engineering evaluation showed that the returned delivery catheter for the product ((b)(4)) exhibited polyimide guidewire lumen detachment at the leading end of the trailing olive junction.It appeared that the detachment was due to the lack of bonding between the polyimide guidewire lumen and trailing olive.The root cause for the lack of bonding between the polyimide guidewire lumen and trailing olive could not be determined based on the currently available information.However, the event description states that the physician pulled back the undeployed device into the sheath, there was a resistance felt, surgeon pulled and the device opened.The gore® excluder® aaa endoprosthesis instructions for use (ifu) states, ¿warning: do not attempt to withdraw any undeployed endoprosthesis through the introducer sheath.The sheath and catheter must be removed together¿.Based on the available information and evaluation of the returned portion of the product, the root cause for the polyimide detachment could not be determined at this time.However, use outside the ifu was noted, and may have contributed to this event.This type of occurrence will continue to be trended and appropriate actions will be taken as they are deemed necessary.The guidewire and the introducer sheath used for the event were not returned, and therefore unavailable for engineering evaluation.The ifu also 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 separation and reintervention.Additionally, according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to improper component placement and occlusion of device or native vessel.(b)(4).

• Brand Name: GORE® EXCLUDER® AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: nataliya baramzina ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4935872
• MDR Text Key: 6051913
• Report Number: 2953161-2015-00080
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2015

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 Expiration Date: 01/31/2018
• Device Catalogue Number: PXC121200
• Device Lot Number: 13574675
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2015
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR