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

Catalog Number PLC121400J

Device Problems Material Invagination (1336); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907)

Patient Problem Calcium Deposits/Calcification (1758)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

On (b)(6) 2018, the patient underwent endovascular treatment of an abdominal aortic aneurysm with gore® excluder® aaa endoprostheses.It was reported, the patient¿s left external iliac artery was calcified.According to the report, after placement of the contralateral leg component within the patient¿s calcified left iliac artery, an attempt was made to withdraw the delivery catheter.It was reported, during withdrawal of the delivery catheter, strong resistance was encountered.Upon removal of the delivery catheter it was observed that the leading proximal olive had completely detached from the delivery catheter and remained within the patient.A snare catheter was successfully used to retrieve the detached olive from the patient.Reportedly, intra-procedure imaging showed the distal portion of the contralateral leg component appeared not to have fully expanded.In order to ensure radial force, the physician elected to implant a bare metal stent within the distal portion of the device with extension into the left external iliac artery.No further adverse events were reported and the patient was reported to have tolerated the procedure.According to the physician, the resistance encountered during withdrawal of the device was due to the area of calcification within the left iliac artery.The physician further stated this calcification resulted in narrow access and incomplete distal expansion of the device, causing the leading olive to separate from the delivery catheter.Reportedly, the delivery catheter was discarded by facility and therefore is not available for evaluation.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7584880
• MDR Text Key: 111056411
• Report Number: 3013164176-2018-00047
• 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: 06/07/2018

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: 02/11/2021
• Device Catalogue Number: PLC121400J
• Device Lot Number: 17772331
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2018
• 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: 78 YR