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

Catalog Number JHJR060202J

Device Problem Complete Blockage (1094)

Patient Problems Hemorrhage/Bleeding (1888); Thrombosis (2100)

Event Date 09/01/2018

Event Type  Injury  

Event Description

The following publication was reviewed: a case of delayed blood flow during viabahn implantation for bleeding from a pseudoaneurysm in the hepatic artery on an unknown date, a patient underwent a total gastrectomy, partial liver resection, partial transverse colectomy and cholecystectomy for residual gastric cancer.Ten days following the procedure the patient exhibited hypotensive shock.A ct showed a pseudoaneurysm at the origin of the left haptic artery.The hypotensive shock was deemed to be caused by bleeding from the pseudoaneurysm.It was decided the bleeding would be addressed endovascularly.First the middle hepatic artery was coiled to block the retrograde blood flow to the pseudoaneurysm.A gore® viabahn® endoprosthesis with heparin bioactive surface (6.0 x 25 mm) was then implanted from the proper hepatic artery to the right hepatic artery to exclude blood flow to the pseudoaneurysm.However, soon after the endoprosthesis was implanted, blood flow to the right hepatic artery disappeared.It was considered that thrombosis may be involved in the issue.Two metallic coronary artery stents were additionally implanted, and the issue was resolved.The article further stated that viabahn has an indication for traumatic or iatrogenic vessel injury with uncontrolled bleeding, however, often it is not possible to use antiplatelet drugs or heparin before the procedure when we use the device for hemostasis, and care must be taken with intraoperative thrombosis.In this case, the procedure was performed under non-administration of heparin, and ¿accordion phenomenon¿ caused by a guide wire was observed, it is considered that thrombus was easily formed.We should take countermeasures such as flushing the catheter frequently with saline.

Manufacturer Narrative

The publication date is being used as the date of event.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8165402
• MDR Text Key: 130381334
• Report Number: 2017233-2018-00768
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

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 Catalogue Number: JHJR060202J
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 80 YR