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U.S. Department of Health and Human Services

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

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W. L. GORE & ASSOCIATES, INC. GORE® VIATORR® TIPS ENDOPROSTHESIS WITH CONTROLLED EXPANSION; SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS Back to Search Results
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.
 
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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 Key15572845
MDR Text Key302729614
Report Number3007284313-2022-02152
Device Sequence Number1
Product Code MIR
UDI-Device Identifier00733132635047
UDI-Public00733132635047
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040027
Number of Events Reported1
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberPTB8108275
Device Catalogue NumberPTB8108275
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/16/2022
Initial Date FDA Received10/10/2022
Supplement Dates Manufacturer Received10/19/2022
Supplement Dates FDA Received10/20/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/16/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age54 YR
Patient SexFemale
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