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

Catalog Number JHH111002J

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Embolism (1829); Thrombosis (2100)

Event Date 02/01/2018

Event Type  Injury  

Manufacturer Narrative

Lot/serial: 16546839, (b)(4).

Event Description

On (b)(6) 2018, the patient underwent endovascular repair of a descending thoracic aortic aneurysm using conformable gore® tag® thoracic endoprostheses.As the patient¿s access vessel condition was not good with pre-existing calcification present, an attempt was made to pre-dilate the access vessel using a 16-fr gore® dryseal sheath with hydrophilic coating.Some resistance was met while the introducer sheath was being advanced, and an angiography revealed a rupture of the left external iliac artery.It was reported that the patient¿s access vessel diameter was 5.1 mm ¿ 6.4 mm.A gore® viabahn® endoprosthesis (jhh111002j/16546839) was implanted to repair the rupture.Then, a 22-fr gore® dryseal flex introducer sheath was advanced from a puncture site in the left common femoral artery.The delivery catheter was advanced through the 22-fr sheath and two endoprostheses were successfully deployed.Upon withdrawal of the 22-fr sheath, dissection of the left common femoral artery was suspected with this artery not being visible on an angiography.Additionally, bleeding was revealed from the puncture site.An attempt was made to repair the access site dissection and bleeding, but it was difficult to advance the guidewire.It took a long time to achieve the guidewire access, which resulted in thrombosis of access vessel from the left external iliac artery including the existing gore® viabahn® endoprosthesis to the left common femoral artery.Thrombectomy was performed to treat the thrombosis, but during this procedure, the remaining thrombus spread distally and occluded the blood vessels of the left lower extremity.Then, another gore® viabahn® endoprosthesis as well as non-gore manufactured vascular stent were implanted from the left external iliac to the left common femoral arteries to repair the access site dissection and bleeding.The patient tolerated the procedure.On (b)(6) 2018, a computed tomography (ct) was run, revealing that the access site bleeding was resolved, though the patient¿s hemoglobin level dropped.Also, further health problems relating to occlusion of the left lower extremity were not revealed.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: yutaka uchiya ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7308966
• MDR Text Key: 101359253
• Report Number: 2017233-2018-00145
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P130006
• 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: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/21/2020
• Device Catalogue Number: JHH111002J
• Device Lot Number: 16546839
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2017
• 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; Required Intervention
• Patient Age: 76 YR