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

Catalog Number PLA320400J

Device Problem Material Separation (1562)

Patient Problem Tissue Damage (2104)

Event Date 10/14/2016

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2016, the patient underwent treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.During the procedure, the physician tried to advance an aortic extender component pla320400j/15155948 using an introducer sheath, however, there was a difficulty advancing the sheath to an intended site due to calcification and tortuosity in the left iliac arteries.So the physician decided to advance the device outside the sheath.While he was advancing the device, the delivery catheter got stuck in the left external iliac artery.The physician pulled the delivery catheter to remove it once from the patient, and then the proximal end of the catheter was separated.The separated proximal end of the catheter with the endoprosthesis constrained left in the left external iliac artery.The physician surgically opened the left external iliac artery and removed the separated portion from the patient.Then he advanced another introducer sheath from the left internal iliac artery and implanted two aortic extender components in the intended site.An endarterectomy was performed at the same time for the left external iliac and then the left external iliac artery was closed.The patient tolerated the procedure.

• 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: izumi ishikawa ; 9285263030
• MDR Report Key: 6084522
• MDR Text Key: 59335349
• Report Number: 2953161-2016-00224
• 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: 10/14/2016

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: 06/08/2019
• Device Catalogue Number: PLA320400J
• Device Lot Number: 15155948
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2016
• 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): Other; Required Intervention
• Patient Age: 74 YR