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

Catalog Number JHH101002J

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Infarction, Cerebral (1771); Thromboembolism (2654)

Event Date 02/13/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® viabahn® endoprosthesis instructions for use (ifu), device- and/or procedure-related complications and adverse events include, but are not limited to distal embolism.Device udi lot/serial: 15852332, udi: (b)(4).

Event Description

On (b)(6) 2018, the patient underwent endovascular reintervention to treat a retrograde thoracic aortic dissection which had been formed around the proximal end of an existing endoprosthesis.A conformable gore® tag® thoracic endoprosthesis was implanted proximal to the existing endoprosthesis.A gore® viabahn® endoprosthesis (jhh101002j/15852332) was also deployed as a chimney device in the left subclavian artery.Intra-procedure imaging revealed a suspected cerebral infarct with the patient¿s consciousness level being deteriorated.It was reported by the physician that thrombus in the aortic arch spread, which could have caused or contributed to the suspected cerebral infarct.It was determined that the endovascular reintervention would be concluded first, followed by an intervention being performed to treat the suspected cerebral infarct.Another conformable gore® tag® thoracic endoprosthesis was implanted.The patient tolerated the procedure and a neurosurgeon underwent an intervention for the suspected cerebral infarct.A brain ct was performed but any apparent vessel obstruction was not confirmed.The neurosurgeon elected to monitor the suspected cerebral infarct.

• 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: 7295447
• MDR Text Key: 100891053
• Report Number: 2017233-2018-00127
• 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: 02/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/21/2019
• Device Catalogue Number: JHH101002J
• Device Lot Number: 15852332
• 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: 09/21/2016
• 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: 80 YR