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

Catalog Number PTB106275

Device Problems Partial Blockage (1065); Complete Blockage (1094)

Patient Problems Occlusion (1984); Thrombus (2101); Stenosis (2263)

Event Date 02/24/2018

Event Type  Injury  

Manufacturer Narrative

Citation: d.Raissi, e.A.Roney, m.M.Issa, s.Sanampudi, m.A.Winkler.Early tips failure in association with left mesenterico-gonadal spontaneous portosystemic venous shunt; a case report.Clinical imaging 2019.(53): 200-203.The gore® viatorr® tips endoprosthesis instructions for use list shunt stenosis or occlusion as adverse events that may occur and/or require intervention due to the tips procedure or underlying liver disease.Additionally, the instructions for use state, "thrombus formation in the tips usually occurs early and may be caused by hypercoaguable syndromes, inadequate coverage of the tips tract, leakage of bile into the tract, or technical complications during the procedure.".

Event Description

The following information was received through literature article "early tips failure in association with left mesenterico-gonadal spontaneous portosystemic venous shunt; a case report" published in clinical imaging, 2018.The article reports a gore® viatorr® tips endoprosthesis was selected for a transjugular intrahepatic portosystemic shunt procedure in a patient with child-pugh grade c liver cirrhosis, secondary to alcohol abuse and hepatitis c virus.The procedure was technically successful, however, despite this therapy, the patient experienced recurrent hematochezia and a computed tomographic angiography on day six post-procedure demonstrated a tips stent occlusion.On day seven post-procedure, aspiration thrombectomy was performed followed by maceration thrombectomy.Post thrombectomy portal vein angiography demonstrated moderate improvement in the luminal caliber of the tips and unanticipated hepatofugal flow.A 14mm self-expanding bare metal stent was deployed in the tips and portal vein to resolve residual thrombus related stenosis.Hepatofugal flow was determined to be from competing large inferior mesenteric vein varices shunting into the left renal vein via the left gonadal vein.Coil embolization of the portal end of the shunt was then performed using multiple detachable coils.After embolization, hepatopetal flow was restored.Between his successful discharge and six-month follow-up, the patient did not experience any recurrent bleeding.

Manufacturer Narrative

B.3.Date of event: (b)(6) 2018.

Manufacturer Narrative

B.5.(describe event or problem): additional information from the article states that, "in this case, the left mesenterico-gonadal shunt caused tips thrombosis within the first week by shunting blood flow away from the tips stent.".

Manufacturer Narrative

Added information to h4.(device manufacture date): 12/5/2017.

• Brand Name: GORE VIATORR TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8848183
• MDR Text Key: 152917906
• Report Number: 3007284313-2019-00230
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2020
• Device Catalogue Number: PTB106275
• Device Lot Number: 17519141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 43 YR
• Patient Weight: 94