MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN ENDOPROSTHESIS - 3; NIP

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Code Available (3191)

Event Date 04/20/2019

Event Type  Injury  

Manufacturer Narrative

Since no patient id is available, the gore event number was used as the patient identifier.The patient age and patient gender reflects the mean age and gender stated in the article.The date of online publication was used as the event date.Lot/serial numbers were not provided, therefore, a review of the manufacturing records could not be conducted.

Event Description

The following publication was reviewed: ¿one-year outcomes of the begraft stent graft used as chimney graft in conjunction with the endurant device for the treatment of complex abdominal diseases¿ (gergana t taneva et.Al, vacular, published online 20-apr-2019).The article analyzes 27 patients with pararenal aortic pathologies between 2008 and 2017 using endurant ii (medtronic, santa rosa, ca, usa) abdominal endograft in combination with gore viabahn® endoprosthesis or begraft (bentley, hechingen, germany).11 patients were treated using endurant ii abdominal endograft in combination with 21 gore viabahn® endoprosthesis that served as chimney grafts.The article includes the following case: early type ia endoleak (in first month) identified in 4 patients with 9 affected gore viabahn® endoprostheses and late type ia endoleaks identified in 2 patients related to 5 gore viabahn® endoprostheses.It was also stated that primary relining was performed in 8 patients (related to 14 grafts) and a reintervention was performed in 2 patients (related to 5 grafts).

• Brand Name: GORE VIABAHN ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: joerg kersten ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9108466
• MDR Text Key: 162942938
• Report Number: 2017233-2019-00887
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 76 YR