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

Catalog Number PLA360400

Device Problems Break (1069); Off-Label Use (1494); Component or Accessory Incompatibility (2897); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  Injury  

Manufacturer Narrative

Udi: (b)(4).The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in patients with pending rupture or ruptured aneurysms.Additionally, the safety and effectiveness of the gore® excluder® aaa endoprosthesis have not been evaluated in the revision of previously placed stent grafts.The ifu also states: ¿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.¿ ¿do not attempt to withdraw any undeployed endoprosthesis through the introducer sheath.The sheath and catheter must be removed together.¿ ¿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

On (b)(6) 2017, a patient underwent treatment of a ruptured abdominal aortic aneurysm (aaa) secondary to a proximal type i endoleak on a previously implanted non-gore device.It was reported that during advancement of a gore® excluder® aaa endoprosthesis aortic extender component, the device had difficulty advancing over the guidewire past the overlap of the previously implanted non-gore device.According to the report, a decision was made to remove the device and withdraw the device into the sheath.No resistance was reportedly noted during withdrawal.It was reported a cutdown was then performed on the femoral artery, and the sheath and partially deployed device were removed from the guidewire via the cut down opening.It was reported the sheath was then reinserted into the femoral artery, at which point it was determined the leading olive from the aortic extender component had detached and remained within the distal limb of the previously implanted non-gore device.According to the report, a snare catheter was used to successfully remove the detached leading olive.Three aortic extender components were then reportedly implanted for proximal extension on the non-gore device.It was reported final angiography showed complete exclusion of the ruptured aaa with no evidence of endoleak, and the patient left the operating room in stable condition.Additional information has been requested.

Event Description

It was reported that during advancement of a gore® excluder® aaa endoprosthesis aortic extender component, the device had difficulty advancing over the guidewire past the overlap of the previously implanted non-gore device.According to the report, a decision was made to remove the device and withdraw the device into the sheath.No resistance was reportedly noted during withdrawal.According to the report, the aortic extender component partially deployed during attempted withdrawal of the device into the sheath.It was reported a cutdown was then performed on the femoral artery, and the partially deployed device was removed from the guidewire via the cutdown opening.It was reported the sheath was then reinserted into the femoral artery, at which point it was determined the leading olive from the aortic extender component had detached and remained within the distal limb of the previously implanted non-gore device.According to the report, a snare catheter was used to successfully remove the detached leading 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: claire west ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7182757
• MDR Text Key: 97751903
• Report Number: 2953161-2018-00004
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 02/22/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2020
• Device Catalogue Number: PLA360400
• Device Lot Number: 16366013
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2017
• 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: 80 YR