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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Abscess (1690)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Bucher jn, hollenbach m, strocka s, gaebelein g, moche m, kaiser t, bartels m, hoffmeister a.Segmental intrahepatic cholestasis as a technical complication of the transjugular intrahepatic porto-systemic shunt.World j gastroenterol 2019; 25(43): 6430-6439.Doi: https://dx.Doi.Org/10.3748/wjg.V25.I43.6430.Device information was not provided; therefore, an investigation is unable to be performed and a cause of the reported event cannot be determined.

Event Description

This information was received through literature article "segmental intrahepatic cholestasis as a technical complication of the transjugular intrahepatic porto-systemic shunt" published online in the world journal of gastroenterology, 21 november 2019.The article states, ¿segmental intrahepatic cholestasis caused by transjugular intrahepatic portosystemic shunt (tips) (sic-t), is a rare complication of this technique and only referred by case reports.Thus, we conducted a systematic, retrospective analysis to provide evidence regarding prevalence and consequences of this tips-induced bile duct compression.In order to identify prevalence and consequences of sic-t in a large cohort, we evaluated all consecutive patients who underwent tips implantation or tips-revision at our institution since 2005." the article reports that 4 cases (2.9%) of sic-t were identified in direct proximity of the tips-stent.Diagnosis was confirmed by ct-scan, mri or endoscopic retrograde cholangio pancreaticography.Sic-t can be defined as segmental cholestasis due to the mechanical obstruction of intrahepatic biliary branches by the stent graft after tips-procedure.This resulted in the significant congestion of the biliary system proximal to the obstructed intrahepatic bile duct in all identified cases.Case #4 describes a (b)(6) year-old male with a child b cirrhosis and budd-chiari syndrome.A first tips-attempt in another hospital for refractory ascites failed because of an atypical portal and hepatic venous anatomy.A single hepatic vein drained mainly the right liver lobe with multiple collaterals combined with an atypical portal-venous anatomy.A gore® viatorr® tips endoprosthesis placement was achieved through an atypical approach from the sole right hepatic vein into an atypically located portal branch.Ct-scan indicated a segmental cholestasis and a cholangitic abscess in liver segment i that was treated with a percutaneous drain.Antibiotics were prescribed.An angiography of the drain showed a connection of the abscess with the segmental bile duct that appeared to be compressed by the tips-stent.Lab values decreased at baseline levels after two weeks.Further follow-up was unremarkable.

• 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: 10102648
• MDR Text Key: 195141705
• Report Number: 3007284313-2020-00138
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 44 YR