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

Catalog Number PXC141400

Device Problems Detachment Of Device Component (1104); Premature Activation (1484); Physical Resistance (2578); Difficult to Advance (2920)

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

Event Date 06/25/2015

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.

Event Description

On (b)(6) 2014, the patient underwent treatment of abdominal aortic aneurysm with gore® excluder® aa endoprosthesis.It was reported, the patient's left iliac artery was extremely tortuous causing difficulty with the advancement of the contralateral leg component.An effort was made to advance the graft outside of the sheath and into the contralateral gate.It was reported as the device was being advanced outside of the sheath resistance was met.The resistance was reportedly due to the patient's tortuous anatomy.An attempt was made to pull the device back into the sheath in order to remove the graft.As the catheter was being withdrawn, it was reportedly noted that the device had prematurely deployed inside of the sheath.The leading olive reportedly completely detached from the delivery catheter.The olive separation was reportedly due to getting caught on the sheath while being withdrawn.It was reported the olive was snared and removed from the patient.The device was set aside and another device was used to complete the procedure with no further issues reported.The device is being returned for evaluation.

Manufacturer Narrative

(b)(4).Corrected the conclusion code.Refer to the evaluation summary below for the results of the engineering evaluation.Corrected.Evaluation summary - the device was returned to gore for evaluation.Engineering observed that the guidewire and the introducer sheath used for the event were not returned, and therefore unavailable for engineering evaluation.The evaluation also observed the returned delivery catheter for the product ((b)(4)) exhibited polyimide guidewire lumen detachment at the leading end of the trailing olive junction.It appeared that the detachment was due to polyimide guidewire lumen¿s tensile failure while the trailing junction is intact.The detached polyimide guidewire lumen was not returned, therefore unavailable for evaluation.The review of the lot history record verified that the lot met the pre-released specification and the acceptance criteria.Based on the available information and evaluation of the returned portion of the product, the root cause for the polyimide detachment could not be determined at this time.However, use outside the ifu was noted, and may have contributed to this event.

Event Description

On (b)(6) 2015, the patient underwent treatment of abdominal aortic aneurysm with gore excluder aaa endoprosthesis.

• 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: marcos ayala ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4933245
• MDR Text Key: 22724764
• Report Number: 2953161-2015-00078
• 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: Other
• Report Date: 09/10/2015

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: 02/28/2018
• Device Catalogue Number: PXC141400
• Device Lot Number: 13690868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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: 89 YR