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

Catalog Number PXC141400

Device Problems Difficult to Insert (1316); Premature Activation (1484)

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

Event Date 06/10/2015

Event Type  malfunction  

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 patient had an excessive tortuous anatomy and the length from renal arteries to hypogastric was 210mm on each side.The physician was unable to insert a gore® dryseal sheath (dsl1228/unknown) into the contralateral gate because the sheath was too short due to the patient¿s anatomy.A decision was made to advance a contralateral leg component (pxc141400/ 13814297) outside the sheath, but this was unsuccessful.Reportedly, the physician felt some resistance.It was reported that during withdrawal of the device back into the sheath, it was noted that the device unintentionally deployed 2cm proximally.The physician was able to extract the device from the sheath.The procedure was concluded with no further issue, and the patient tolerated the procedure.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Event description.(b)(4).The delivery catheter was sent to gore for analysis.The guidewire and the introducer sheath used for the event were not returned, and therefore unavailable for engineering evaluation.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 a polyimide guidewire lumen¿s tensile failure while the trailing olive junction remained intact.The detached polyimide guidewire lumen was not returned, and therefore unavailable for engineering evaluation.The event description states that the physician decided to remove the device through the sheath and the device was deployed.The gore® excluder® aaa endoprosthesis instructions for use 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, no root cause could be determined at this time.However, use outside of 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.Additionally, the ifu states,¿ do not advance the device outside of the sheath.The sheath will protect the device from catheter breakage or premature deployment while tracking it into position.Do not continue advancing any portion of the delivery system if resistance is felt during advancement of the guidewire, sheath, or catheter.Stop and asses the cause of resistance.Vessel or catheter damage may occur.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.¿.

Event Description

The physician was able to extract the device from the sheath and used another contralateral leg component to complete the procedure.

• 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: 4859542
• MDR Text Key: 5807443
• Report Number: 2953161-2015-00065
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 08/14/2015

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: 03/31/2018
• Device Catalogue Number: PXC141400
• Device Lot Number: 13814297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2015
• 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 Age: 84 YR
• Patient Weight: 82