MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIATORR® TIPS ENDOPROSTHESIS; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS

Catalog Number PTB107275

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Biliary Cirrhosis (1736); Death (1802); Encephalopathy (1833); Hypoxia (1918); Respiratory Failure (2484); Blood Loss (2597)

Event Date 08/21/2015

Event Type  Death  

Manufacturer Narrative

A device lot number was not provided; therefore, an investigation was unable to be performed and a cause of the reported event was unable to be determined.Sakib, s m nazmus, kobayashi, katsuhiro, jawed, mohammed.Potential pitfalls in transjugular portosystemic shunt placement for bleeding rectal varices.Case reports in gastroenterology.2015; 9:296-301.

Event Description

This information was received through case report ¿potential pitfalls in transjugular portosystemic shunt placement for bleeding rectal varices¿ published in case reports of gastroenterology, 21 august 2015.The abstract reports a case of massive bleeding from large rectal varices in a (b)(6) man with alcoholic cirrhosis.Emergent transjugular intrahepatic portosystemic shunt (tips) placement was performed (10 × 90 mm viatorr stent-graft) following failed local endoscopic therapy.Despite normalization of the portosystemic pressure gradient, the patient had another episode of massive bleeding on the following day.Embolization of the rectal varices via tips successfully stopped the bleeding.After the procedure, rapid decompensation of the cirrhosis led to severe encephalopathy.Despite maximal medical management, his clinical condition continued to deteriorate.He developed acute hypoxic respiratory failure secondary to multiple causes, including progressive liver failure.He required mechanical ventilation and became minimally responsive.Palliative care was instituted.He died 2 weeks after the tips placement.

Manufacturer Narrative

Lot number 10786197: (b)(4).The articles states a 10 × 90 mm viator stent-graft was implanted; however, the lot number provided by the author is a 10mm x 7cm device.

• Brand Name: GORE VIATORR® TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6497972
• MDR Text Key: 72939057
• Report Number: 3007284313-2017-00091
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: PTB107275
• Device Lot Number: 10786197
• 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: 10/08/2012
• 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): Death; Other
• Patient Age: 59 YR