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

Catalog Number PTB086275W

Device Problems Separation Failure (2547); Activation Failure (3270)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

Patient weight was unavailable.A review of the manufacturing records indicated the device met pre-release specifications.Neither clinical images enabling assessment of product performance was returned for evaluation nor the product itself (remains implanted) was accessible for testing, the investigation could not be performed.Cause of the event cannot be established based on the available information.Further information regarding this event was requested by gore, but no further information has been reported, therefore, this investigation is considered complete.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

The following was reported to gore: on (b)(6) 2022, a patient was to be implanted with a 8mm x 6cm gore® tips viatorr® (viatorr® device) during a tips procedure.The viatorr® device was advanced to the target lesion.The unlined region of device expanded successfully.The deployment knob was pulled, it was found that the viatorr® device couldn't complete the expansion at around 0.5-1cm away from head end (proximal end) and the deployment line stuck.Physician tried to twist the delivery catheter, but the device still couldn't complete the expansion.A balloon was used to dilate the device to 26 atmospheres, trying to expand the device, the deployment line showed a little loose but the device couldn't fully expand by pulling the deployment line.Due to there was no good solution after consulting physicians from different departments, the physician decided to cut the deployment line that was outside patient and have other parts left in patient with one end tied to device.Patient tolerated the procedure, situation was stable and discharged from hospital.

• 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: qiong wang ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15367936
• MDR Text Key: 305982087
• Report Number: 3007284313-2022-02101
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PTB086275W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Male