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

Catalog Number PXC141400J

Device Problems Sticking (1597); Failure to Advance (2524); Malposition of Device (2616)

Patient Problem No Code Available (3191)

Event Date 09/09/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, the patient underwent an endovascular procedure using a gore® excluder® aaa endoprosthesis featuring c3® delivery system to repair an abdominal aortic aneurysm.The patient's left external iliac artery was highly calcified, with the diameter of 3-6mm.It was reported that advancement of a gore® dryseal sheath with hydrophilic coating (dsl1228j/12778970) for implanting a contralateral leg component (pxc141400j/12616829) at the left side was not possible due to the calcification, and that a ballooning to the left external iliac artery did not help the advancement.The physician elected to advance the device outside the sheath, however the device was stuck at the aortic bifurcation and did not advance any further.The physician elected not to implant the device and during retracting the device it was stuck at the external iliac artery and then only the delivery catheter was eventually retracted.It was confirmed that the device was unintentionally deployed at the external iliac artery.The physician decided to leave the device in the artery.The patient tolerated the procedure.

Manufacturer Narrative

Updated results and conclusions code: the review of the manufacturing paperwork verified that this lot met all pre-release specifications.

• 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: miyuki kurihara ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4154148
• MDR Text Key: 4784600
• Report Number: 2953161-2014-00111
• 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: 10/15/2014

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: 04/30/2017
• Device Catalogue Number: PXC141400J
• Device Lot Number: 12616829
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2014
• 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): Other
• Patient Age: 85 YR