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

Catalog Number PXC121200J

Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Physical Resistance (2578)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/14/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device(s) verified that the lot(s) met all pre-release specifications.The gore® excluder® aaa endoprosthesis, instructions for use (ifu) warns: ¿do not continue advancing 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.¿ additionally, the ifu warns: ¿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.¿.

Event Description

On (b)(4) 2017, the patient underwent endovascular repair of a left common iliac artery aneurysm using a gore® excluder® aaa endoprosthesis, contralateral leg component (pxc121200j/15725737).Prior to the endoprosthesis being deployed, the left internal iliac artery was embolized.The physician attempted to advance a 14-fr gore® dryseal sheath with hydrophilic coating (dsl1428j/unknown lot number), but it was difficult to advance the sheath into an intended position.A delivery catheter for contralateral leg component was then inserted outside of the sheath, but it could not be advanced beyond a tortuous portion of the left common iliac artery.Several attempts were made to advance the delivery catheter, but those were not successful, and the contralateral leg component began to deploy.The physician decided to pull the delivery catheter backwards but it was not successful, resulting in the contralateral leg component being completely deployed with its proximal end implanted approximately 1cm into the abdominal aortic bifurcation.When the delivery catheter was removed outside of the patient, it was revealed that a leading end of the delivery catheter was detached from the catheter body.A snare catheter was advanced and the detached portion of the delivery catheter was retrieved outside of the patient.The physician tried to reposition the contralateral leg component using a balloon catheter, but it was unsuccessful.Intra-procedure angiography was run, revealing that blood flow to the right common iliac artery was maintained, so that the procedure was concluded without further intervention being performed for the contralateral leg component.

Manufacturer Narrative

The gore® excluder® aaa endoprosthesis instructions for use (ifu) clearly 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 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.Do not attempt to withdraw any undeployed endoprosthesis through the introducer sheaths.The sheath and undeployed device must be removed together.The cause for the broken leading end of the catheter could not be determined with the currently available information.Use outside the ifu likely contributed to the broken leading end of the catheter, specifically advancing outside the sheath.(b)(4).

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of a left common iliac artery aneurysm using a gore® excluder® aaa endoprosthesis, contralateral leg component.During the procedure it was reported that there was difficulty advancing a 14-fr gore® dryseal sheath with hydrophilic coating (dsl1428j) to the intended position for deployment of the contralateral leg component.The device was advanced outside the sheath and multiple attempts were made to maneuver the device past a tortuous section of the left common iliac artery however the distal end was unable to advance past the tortuous section and the contralateral leg component began to unintentionally deploy.It was decided to withdraw backwards on the delivery catheter but this resulted in the contralateral leg component being completely deployed with the proximal end positioned approximately 1cm into the abdominal aortic bifurcation.When the delivery catheter was removed outside of the patient, it was revealed that a leading end of the delivery catheter was detached from the catheter body, the deployment line was intact.A snare catheter was advanced and the detached portion of the delivery catheter was retrieved and removed from the patient¿s vasculature.Attempts to reposition contralateral leg component he contralateral leg component using a balloon catheter were attempted but unsuccessful.Intra-procedure angiography was run, revealing that blood flow to the right common iliac artery was maintained, so that the procedure was concluded without further intervention being performed for the contralateral leg component.It was reported that advancement outside the sheath is believed to have contributed to the unintentional deployment and the fracture at the trailing olive.

• 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: laura crawford ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6805896
• MDR Text Key: 83259158
• Report Number: 2953161-2017-00160
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/19/2017

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: 11/23/2019
• Device Catalogue Number: PXC121200J
• Device Lot Number: 15725737
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/18/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/14/2017; 09/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2016
• 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: 80 YR