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

Catalog Number PLA280300J

Device Problems Difficult to Remove (1528); Sticking (1597)

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

Event Date 03/13/2017

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Device udi lot/serial: (b)(4), udi: (b)(4).

Event Description

On (b)(6) 2017, the patient underwent endovascular repair of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Prior to the endoprostheses being implanted, chimney stents were deployed in the superior mesenteric and bilateral renal arteries.Trunk-ipsilateral leg, contralateral leg and iliac extender components were deployed below the superior mesenteric artery.Additionally, an aortic extender component (pla280300j/(b)(4)) was deployed proximal to the trunk-ipsilateral leg component, and upon removal of the delivery catheter, it got stuck on the guidewire.The delivery catheter could not be moved so that it was removed together with the guidewire.Another guidewire was inserted and touch-up ballooning was performed.The patient tolerated the procedure.

Manufacturer Narrative

Device available for evaluation: corrected this section to "yes" and added 4/5/2017 as the device return date.Device evaluated by manufacturer: corrected this section to "yes".Results of engineering evaluation: the delivery catheter was returned and an engineering evaluation was performed.Engineering confirmed that the device had been deployed off of the catheter.There was blood on the device indicating that it had been inside the body.No damage or kinks were noted on the delivery catheter.The device was returned with the guidewire still inside the catheter.The guidewire could not be removed from the device by hand.During the attempts to remove the guidewire from the catheter, the braided wraps on the guidewire separated from the guidewire core on the leading end of the guidewire.The catheter remained intact during the guidewire removal attempts.The cause for the guidewire being stuck inside the delivery catheter could not be determined with the available information.

• 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: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6435038
• MDR Text Key: 71203742
• Report Number: 2953161-2017-00066
• 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
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2019
• Device Catalogue Number: PLA280300J
• Device Lot Number: 15099745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2016
• 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: 64 YR