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

Device Problem Expulsion (2933)

Patient Problems Ascites (2596); Foreign Body Embolism (4439)

Event Date 07/20/2023

Event Type  Injury  

Manufacturer Narrative

The gore® viatorr® tips endoprosthesis with controlled expansion instructions for use (ifu) note prosthesis migration as a possible adverse event.Additionally, the ifu states, "care should be taken to not displace a deployed gore® viatorr® tips endoprosthesis with controlled expansion by re-introduction of an introducer sheath or back through the endoprosthesis.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

Event Description

This information was received through literature article " viatorr stent migration and retrieval during transjugular intrahepatic portosystemic shunt revision" published online 20 july 2023, in seminars in interventional radiology.The article reports a 7cm gore® viatorr® tips endoprosthesis with controlled expansion was implanted.Intrastent angioplasty was performed to a diameter of 8mm.After tips and variceal embolization, the mean portosystemic gradient decreased from 28 to 16 mm hg.Due to concern for his elevated risk of hepatic and cerebral morbidity, the decision was made to not dilate the tips stent further during this procedure.The plan was to reintervene should he fail to improve clinically.His postprocedural course after tips placement and variceal embolization was notable for continued blood transfusion and pressor requirements.He was brought back to ir for tips stent revision.The tips was accessed using an mpa catheter and guidewire.After access, it was recognized that the tips stent had migrated caudally into the portal vein.Balloon-mediated retraction was attempted to reposition the stent; however, this attempt was unsuccessful.Next, forceps-mediated repositioning was attempted, but this was also unsuccessful.A decision was then made to remove the stent, which was accomplished with a looped glidewire technique.The viatorr stent was retracted out of the liver and to the end of the sheath, but it could not fit within the sheath lumen.The venotomy site incision was made larger, then the stent and sheath were removed in entirety.After removal of the migrated stent, a new 7cm gore® viatorr® tips endoprosthesis with controlled expansion was placed in the same tract.Post-placement angioplasty was performed with a conquest 10 mm x 4 cm balloon catheter.After tips replacement, additional embolization of splenic varices was performed using coils.His intraprocedural course was notable for accumulation of intraperitoneal blood, visualized as free intraperitoneal fluid on ultrasound imaging.This was presumed to be related to the time interval during which the hepatic and portal vessels remained uncovered by a stent.A drain was inserted into the peritoneal space and yielded 1 l of old blood.Residual hemoperitoneum could be seen on a follow-up ct.Post procedurally, he became hemodynamically stable; however, he required prolonged admission for the management of multiple medical and surgical issues related to his critically ill presentation and tips placement.

Manufacturer Narrative

Literature citation: kim sh, samuel m, makramalla a.Viatorr stent migration and retrieval during transjugular intrahepatic portosystemic shunt revision.Semin intervent radiol.2023 jul 20;40(3):269-273.Doi: 10.1055/s-0043-1769772.Pmid: 37484444; pmcid: pmc10359121.Attached literature article.

• Brand Name: GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17940468
• MDR Text Key: 325744569
• Report Number: 3007284313-2023-02828
• 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: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• 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
• Date Manufacturer Received: 09/28/2023
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Male