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

Catalog Number HGB161407A

Device Problems Patient-Device Incompatibility (2682); Component or Accessory Incompatibility (2897)

Patient Problem Not Applicable (3189)

Event Date 02/15/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional device(s) implanted and involved in the event: hgb161207a/15738953.(b)(4).

Event Description

On (b)(6) 2018, the patient underwent endovascular repair of an abdominal aortic aneurysm and a iliac aneurysm using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.It was reported while an internal iliac component was being advanced up and over the aortic bifurcation into the internal iliac artery.Imaging reportedly identified the device was kinked.The physician stated the cause of the device being kinked was the patient's extreme tortuosity.The device was able to be withdrawn from the patient.A second internal iliac component was being advanced up and over the aortic bifurcation into the internal iliac artery.Imaging reportedly identified the device was kinked.The physician stated the cause of the device being kinked was again the patient's extreme tortuosity.The device was able to be withdrawn from the patient.The procedure was concluded with the patient's internal iliac artery being coil embolized.No further adverse events were reported.

Manufacturer Narrative

Upon further investigation, it was determined that this event is not a reportable serious injury.Therefore, this report will be retracted.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH 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 ; 9285263030
• MDR Report Key: 7324868
• MDR Text Key: 101911754
• Report Number: 2953161-2018-00024
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 03/14/2018

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: 09/19/2020
• Device Catalogue Number: HGB161407A
• Device Lot Number: 17255646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/08/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2017
• 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
• Patient Age: 87 YR