MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number RLT281418J

Device Problem Positioning Problem (3009)

Patient Problem No Patient Involvement (2645)

Event Date 06/25/2019

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Refer to the device evaluation summary below for the results of the engineering evaluation.The device was returned to gore for evaluation.The device evaluation showed the following: as reported in the event description, the returned guidewire remained in the device.The returned guidewire showed no signs of damage.The delivery catheter was visually inspected and appeared undamaged, there were no kinks or signs of torsion.The tuohy-borst valve was inspected and appeared to be aligned with the handle spine.No abnormalities were noticed.Engineering attempted to move advance and remove the guidewire but were not able to.The un-deployed device was also inspected.A gap between the leading tip and the graft was found.Additionally, the lock pin was observed to have been dislodged from its seating in the leading olive.Slack in the koretex (2nd deployment) line was also observed.The observations of the dislodged lock pin, the gap between the graft and leading tip are consistent with the guidewire being stuck within the lumen and potential excessive force being used to move it.Engineering deployed the device to inspect the polyimide shaft.The polyimide shaft appeared to be intact.Engineering removed the handle covers in order to visually inspect the guide-wire lumen inside the handle.No abnormalities were observed.With the handle covers removed, engineering was able to move the guidewire back and forth but were met with resistance.Based on the findings from the evaluation of serial/lot# (b)(4), the observation that the guidewire was not able to be advanced further was confirmed.The likely cause for the inability to advance (b)(4) over the guidewire could not be determined with the available information.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment using gore® excluder® aaa endoprostheses for abdominal aortic aneurysm.The rlt281418j was advanced over a guidewire, however, it would not advance.The device was not inserted to patient¿s body.The rlt281418j was removed with the guidewire.A gore® excluder® aaa endoprosthesis rlt281218 was advanced just below the left renal artery.When the device was deployed, the stent graft unintentionally moved distally.Two aortic extender endoprostheses were implanted proximally to the rlt281218.The patient tolerated the procedure.

• Brand Name: AORTIC EXCLUDER AAA ENDOPROSTHESIS (C3)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marcos ayala ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9079142
• MDR Text Key: 159226409
• Report Number: 3007284313-2019-00286
• 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
• Report Date: 06/25/2019

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: 03/11/2022
• Device Catalogue Number: RLT281418J
• Device Lot Number: 20337912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/12/2019
• 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