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

Catalog Number PLC181000J

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/30/2020

Event Type  Death  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications; according to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events with may occur and/or require intervention including, but not limited to, endoleak, embolization with transient or permanent ischemia, and death.

Event Description

On (b)(6) 2020, this patient underwent endovascular treatment of an aortic arch aneurysm using gore® tag® conformable thoracic stent graft with active control system.After 2 debranch bypasses were performed, the first ctag was implanted below the left subclavian artery, then second ctag was implanted in proximally.As a chimney stentgraft, excluder leg (plc181000j/(b)(4)) was also placed in the brachiocephalic artery.At the angiography, endoleak of unknown type was suspected at the inner curvature of the aorta.The procedure was completed.On (b)(6) 2020, the patient expired due to multiple organ failure.The actual onset date of the multiple organ failure was unknown.No further detailed information is available.The physician commented that the patient had a "shaggy aorta" with severely tortuous.Reported it was occurred the shower embolization of clot by delivering of ctag.

• Brand Name: GORE EXCLUDER AAA ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10495298
• MDR Text Key: 205707959
• Report Number: 2017233-2020-01227
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2020

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: 04/20/2023
• Device Catalogue Number: PLC181000J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/04/2020
• Date Device Manufactured: 04/20/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 86 YR