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

Catalog Number PT8108275

Device Problems Fracture (1260); Activation Failure (3270)

Patient Problem Liver Damage/Dysfunction (1954)

Event Date 05/12/2022

Event Type  Injury  

Event Description

It was reported to gore that the patient underwent endovascular treatment for a transjugular intrahepatic portosystemic shunt creation (tips) due to a budd-chiari-syndrom with a gore® viatorr® tips endoprosthesis with controlled expansion (viatorr-device).It was stated that a 10 fr cook flexor introducer sheath was used together with an 0.0035¿ amplatz guide wire.The viatorr-device was inserted and placed without any issues and there was no kinking due to a straight pathway.The uncovered baremetal segment was deployed without any problems.The deployment line of the covered endoprosthesis was pulled at first and the device began to deploy, but suddenly the line appeared to be blocked and broke.As the device was still connected to the delivery catheter, it was not possible to deploy the device.The device had to be removed from the patient with great efforts and the procedure was not finished according to plan.The patient tolerated the procedure.Reportedly, to rule out acute injuries, a ct scan of the thorax and abdomen was carried out immediately afterwards, which was able to exclude a relevant organ injury.The following night the hb decreased so that another ct scan and angiography were performed to rule out acute bleeding.Active bleeding could be excluded.The patient was listed as high urgency for liver transplantation.

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.(b)(4).A product history review, communication/interviews and an engineering investigation of the returned device will be performed.

Manufacturer Narrative

B1: adverse event instead of product problem (e.G., defects/malfunctions).B2: required intervention to prevent permanent impairment/damage (devices).H1: type of reportable event: serious injury instead of malfunction.

Manufacturer Narrative

Images and patient details will not be provided by the hospital.Therefore an imaging evaluation cannot be performed.H6 evaluation codes investigation findings 213 refers to the product history review: a review of the manufacturing records indicated the lots met pre-release specifications.Engineering investigation: - the endoprosthesis was returned partially deployed and without the delivery system.- intermittent sections of the endoprosthesis were unconstrained and constrained by the zipper.- the deployment line appeared to be cut as all four fibers that constitute the zipper/deployment line ended at the same place.- no anomalies were observed in the most distal zipper knot row.The physician¿s observation that the deployment line broke is confirmed, however how or when it broke could not be determined with the available information.With the information provided to gore, the cause of the reported event could not be established.In the instruction for use for the gore® viatorr® tips endoprosthesis with controlled expansion the following is stated: adverse events adverse events may include, but are not limited to: deployment failure, prosthesis/device failure.

• 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: gunter marte ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14630080
• MDR Text Key: 293725157
• Report Number: 3007284313-2022-01955
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: PT8108275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2022
• 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
• Treatment: 10 FR COOK FLEXOR SHEATH, 0.0035¿AMPLATZ
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 37 YR
• Patient Sex: Female