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

Catalog Number RLT261414J

Device Problems Bent (1059); Detachment Of Device Component (1104); Difficult to Remove (1528); Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2016

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).

Event Description

On (b)(6) 2016, the patient underwent treatment of an abdominal aneurysm with gore® excluder® aaa endoprostheses.After a trunk-ipsilateral component (rlt261414j/14929336) was deployed, while the physician was removing the delivery catheter, the leading olive got stuck on the distal end of an introducer sheath.It was reported the external iliac artery was tortuous and the distal end of the sheath was bent due to blood vessel tortuosity.The leading olive got stuck on the bent section of the sheath.The physician pulled the delivery catheter hard and then the leading olive was detached.The detached olive was removed from the patient using a snare catheter and the procedure was completed with no further issues.The patient tolerated the procedure.

Manufacturer Narrative

Adverse event and/or product problem and type of reportable event were corrected.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: izumi ishikawa ; 9285263030
• MDR Report Key: 6130997
• MDR Text Key: 60992457
• Report Number: 3007284313-2016-00240
• 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: 01/10/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2019
• Device Catalogue Number: RLT261414J
• Device Lot Number: 14929336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/29/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 82 YR