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

Catalog Number PTB088275W

Device Problems Material Deformation (2976); Activation Failure (3270)

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

Event Date 06/29/2022

Event Type  malfunction  

Event Description

The following was reported to gore: on (b)(6) 2022 a patient was to be implanted with 8mm x 8cm (ptb088275w) gore® viatorr® tips endoprosthesis (viatorr device) to treat cirrhosis and ascites.After checking the package and flushing the viatorr device, the physician advanced it via 10fr cook sheath to target lesion.It was report it was smooth to advance through valve, and the unlined region was successfully expanded.About half of covered region was expanded smoothly.Then a big resistance was felt, it was found the delivery system was seriously folded when pulling out the deployment line.The physician was worried about the deployment line would be broken in the patient.Therefore, the viatorr device was retrieved from patient after many attempts.Another new viatorr device was used to completed the procedure.The patient tolerated the procedure.

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.

Manufacturer Narrative

A review of the manufacturing records indicated the lots met pre-release specifications.An engineering evaluation was performed based on the videos and pictures gore received.In the image of the endoprosthesis no pertinent information was observed.During the evaluation of videos, the physician¿s observations that resistance was felt and the delivery system was folded are consistent with the video, however, it cannot be determined at what point the resistance and catheter damage occurred nor the potential cause with the information that was provided.An imaging evaluation was performed based on the images gore received.Based on the imaging provided, a gore® viatorr® device appeared to initially be partially deployed within the tips tract.It is unknown what occurred prior to the initial deployment, as there were no available images and videos submitted from the device insertion to initial deployment.In later video clips the viatorr® device is completely deployed, however, it is unknown what events occurred between initial and final deployment as no imaging was providing during that time.After deployment a series of pta balloon dilatations were performed across the device for full expansion and wall apposition.Final imaging shows good flow of contrast through the deployed viatorr® device.Based on the available imaging, gore is unable to determine a potential cause for the reported event.The root cause of this event could not be determined during the investigation.

Event Description

The following was reported to gore: on (b)(6) 2022, a patient was to be implanted with 8mm x 8cm (ptb088275w) gore® viatorr® tips endoprosthesis (viatorr® device) to treat cirrhosis and ascites.After checking the package and flushing the viatorr® device, the physician advanced it via 10fr cook sheath to target lesion.It was reported that the device was smoothly advanced through the sheath and that the unlined region of the endoprosthesis successfully deployed.It was then stated that about half of the covered region of the endoprosthesis deployed smoothly, but then resistance was felt.When pulling out the deployment line, the delivery system was fold.The physician was worried about the deployment line would break in the patient.Therefore, the viatorr® device was retrieved from patient after multiple attempts, and a new viatorr® device was used to completed the procedure.It was reported that the patient tolerated the procedure.

• Brand Name: GORE® VIATORR® TIPS ENDOPROSTHESIS
• 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: pixie xi ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15127212
• MDR Text Key: 304094725
• Report Number: 3007284313-2022-02055
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTB088275W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2022
• 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 Age: 74 YR
• Patient Sex: Female
• Patient Weight: 48 KG