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

Catalog Number PT106275

Device Problems Occlusion Within Device (1423); Activation, Positioning or Separation Problem (2906)

Patient Problems Edema (1820); Renal Failure (2041)

Event Date 07/13/2015

Event Type  Injury  

Event Description

It was reported the physician implanted a gore viatorr tips endoprosthesis in a transjugular intrahepatic portosystemic shunt (tips) procedure.Three weeks following the implant, the patient returned with recurrent large volume ascites and renal failure.Stent occlusion was confirmed.The physician reported finding soft clot in the hepatic vein end of the stent, and firm clot with tissue ingrowth at the other end.A review of the implant procedure images confirmed the likelihood the device was deployed too high into the parenchymal tract, so that the uncovered portion of the stent was in the tract by a few millimeters.The fellow who deployed the stent later confirmed that they suspected the stent may have been pulled too far back during deployment.Additionally, the stent was only post-dilated to 6mm, as the patient had a history of encephalopathy.A revision procedure was performed in which a second viatorr device was implanted with no adverse effects.

Manufacturer Narrative

The investigation is currently ongoing.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 fields indicate that the information was not provided, was deemed unavailable or was not applicable.

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

• Brand Name: GORE VIATORR® TIPS ENDOPROSTHESIS
• Type of Device: SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4939925
• MDR Text Key: 6036622
• Report Number: 3007284313-2015-00080
• Device Sequence Number: 1
• Product Code: MIR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P040027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2015
• Device Catalogue Number: PT106275
• Device Lot Number: 10743602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2012
• 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): Required Intervention