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

Catalog Number PT8107275

Device Problems Break (1069); Activation Problem (4042)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2023

Event Type  malfunction  

Manufacturer Narrative

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

It was reported to gore a gore® viatorr® tips endoprosthesis with controlled expansion was selected for a transjugular intrahepatic portosystemic shunt (tips) procedure to treat high portal pressures.The patient had a liver transplant (b)(6) 2023 and started to show signs of ascites and it was decided to do a tips procedure to minimize symptoms.It was reported the string got stuck and only the distal part of the stent graft was widened and released.The proximal part of the stent graft was stuck on the stent graft catheter.Several attempts were made without success to catheterize the space between the stent graft and the stent graft catheter through the portal catheter.Attempts were made without success to pull the stent graft into the neck introducer, first with a 10-french introducer, then with a 14fr introducer and lastly co-axial with 10/14-french introducers.A large piece of the stent graft catheter was broken off.Attempts were made without success to pull the stent graft into the neck introducer.First with a snare and later with forceps.The introducer broke due to these attempts and was exchanged.When the introducer was exchanged, it was noted that a large part of the stent graft catheter was left and sticking out from the neck.Placement of a micro-pta-balloon in the lumen of the stent graft catheter.Dilatation was made with a 2 mm and a 3 mm balloon.An attempt was done to dilate with a 4 mm balloon, but it did not fit through the lumen of the catheter.The stent graft was slightly widened but still was not released from the catheter.It was decided that the best course of action was to cut the proximal end of the catheter that was sticking out from the neck.The remaining part of the catheter was pushed into the vessel with the introducer and the dilator.The procedure was terminated.The device remains in the patient.1/2/24 received the following update from the fsa: the patient has now been transplanted with a new liver.The viatorr® device was explanted.

Manufacturer Narrative

Product history review: a review of the manufacturing records indicated the lots met pre-release specifications.Device evaluation: the device was returned in four distinct pieces, 1) the deployment knob/line measuring approximately 79 cm long, 2) the catheter hub, 3) a portion of the catheter body approximately 40 cm, and 4) the partially deployed device secured to distal shaft of the delivery catheter.The zipper at the point where deployment stopped was put under magnification.No abnormalities were noted that would prevent the knot rows from releasing from each other.Engineering attempted to pull on the remaining deployment line and was able to release the first knot row, however, was unsuccessful in unfurling the additional knot rows.The physician¿s observation that the deployment line broke halfway through deployment was confirmed.As no abnormalities were noted to prevent the knot rows from releasing from each other, the breaking of the deployment line is likely what prevented further deployment.It could not be determined with the available information at what point or why the deployment line broke.Not enough information was provided to determine the cause of the reported event.Explant evaluation summary: the specimen was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore® viatorr® tips endoprosthesis with controlled expansion that was still attached to a fragment of the delivery catheter and partially encased in a fragment of the patient¿s liver.The device was traversing the liver fragment for approximately 80 mm and extending to the end of the portal vein.Portions of the device were exposed with incremental, partial expansion with intervening non-expanded portions.Approximately 5 mm of the catheter extended beyond the portal aspect of the device.There was no evidence of tissue response to the device and the implanted vasculature was intact other than denuded endothelium and small scattered surface thrombi.These are considered normal and expected findings following the insertion and partial deployment of the device considering the short (16 day) implant duration.There were significant liver abnormalities.There was acute multifocal centrilobular hemorrhage and necrosis.Additionally, there was mild to moderate lymphocytic periportal hepatitis with biliary hyperplasia and endothelial necrosis of central and portal venules.The potential causes of these non-device related lesions are outside the scope of this explant analysis.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the device was examined for material disruptions with the aid of a stereomicroscope.From approximately mid-device going towards the proximal end, the device was not deployed in three regions with two areas of partially deployed device in-between the non-deployed regions.Six holes were present in the eptfe material of the device.The exact time and cause of the holes could not be determined with the information provided.In the deployed region of the device, near the distal end, a stent frame apex was protruding through the eptfe and into the lumen of the device from the non-deployed region.A portion of the deployment line was present, extending from the beginning of the non-deployed region of the device.Disruptions identified were not associated with handling or manufacturing process at w.L.Gore & associates.Imaging evaluation.Summary: the imaging evaluation performed by a clinical imaging specialist showed the following: two radiographic jpeg images are provided for evaluation.No name, date, or demographic information is included on the images.Images appear to show: partial deployment of viatorr® device.The distal portion of the stent graft is undeployed and remains on the deployment catheter.Attempted catheterization of the space between the stent graft and the stent graft catheter with the portal catheter.Possible portion of the stent graft catheter is seen on the 2nd image provided.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18435302
• MDR Text Key: 331865241
• Report Number: 3007284313-2024-02986
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PT8107275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2023
• 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: 59 YR
• Patient Sex: Female