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

Catalog Number PXL161007

Device Problems Sticking (1597); Difficult to Advance (2920)

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

Event Date 01/08/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that this lot met all pre-release specifications.

Event Description

On (b)(6) 2017, a gore® excluder® aaa endoprosthesis (pxl161007/(b)(4)) was to be implanted as extension leg for treatment of an abdominal aortic aneurysm.The physician felt a little bit unsmooth during starting to insert the device via a 0.035 lunderquist guide wire.When the device just being inserted into a sheath by some extra force,the device was reportedly stuck on the guide wire and could not move back or forth.It was stated there had no reported issues for using this same lunderquist guide wire to insert and advance other components before using for this device.The device was retracted through the sheath together with the guide wire.After retraction outside the patient, the physician tried to deploy the device to found the reason of getting stuck, but the catheter was still stuck on the guide wire after the stent was fully deployed.

• 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: helen huang ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6295881
• MDR Text Key: 66673978
• Report Number: 2953161-2017-00028
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: PXL161007
• Device Lot Number: 14626071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/31/2015
• 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: 71 YR
• Patient Weight: 65