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

Model Number PTB8108275

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907)

Patient Problem Unspecified Hepatic or Biliary Problem (4493)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

Weight: no patient weight was available.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 the physician was implanting a gore® viatorr® tips endoprosthesis with controlled expansion.As the device was half-way expanded, the deployment cord broke.A sheath was advanced to the device and the physician attempted to pull the device and catheter into the sheath.While the device was being pulled into the sheath, the distal part of the catheter broke.A wire was advanced from the femoral vein through the device and back out the jugular vein.The device was pushed into the vena cava and a snare was used to remove the half of the device and a forceps was used to remove the remaining half.A new viatorr device was implanted, and the patient was doing well following the procedure.

Manufacturer Narrative

Device evaluation stated the following: the device was returned in three distinct pieces, 1) the deployment knob/line measuring approximately 100 cm long, 2) the body of the delivery catheter and 3) the partially deployed device secured to distal shaft of the delivery catheter.The distal knot row was examined under magnification.No abnormalities were noted that would prevent the knot rows from releasing from each other.Engineering used tweezers to pull on the broken deployment fibers and was able to successfully unfurl 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 why the deployment line broke.Not enough information was provided to determine the cause of the reported event.

• 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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15572845
• MDR Text Key: 302729614
• Report Number: 3007284313-2022-02152
• Device Sequence Number: 1
• Product Code: MIR
• UDI-Device Identifier: 00733132635047
• UDI-Public: 00733132635047
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PTB8108275
• Device Catalogue Number: PTB8108275
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2022
• 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: 54 YR
• Patient Sex: Female