FDA.reportPublic FDA data

MAUDE MDR 7199152

MDR report key
7199152
Report number
3007284313-2018-00020
Event key
0
Event type
3
Date of event
2017-12-22
Date received
2018-01-17
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MARCI STEWART
Address
1500 N. 4TH STREET FLAGSTAFF AZ
Phone
928-928-9285
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GORE? VIATORR? TIPS ENDOPROSTHESISSHUNT, PORTOSYSTEMIC, ENDOPROSTHESISW.L. GORE & ASSOCIATESMIRPTB10827517385379Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-01-1701. O

Event Narratives#

N

Patient 1

A REVIEW OF THE MANUFACTURING RECORDS VERIFIED THE LOT WAS PROCESSED NORMALLY AND ALL PRE-RELEASE SPECIFICATIONS WERE MET. UDI: (B)(4).

D

Patient 1

IT WAS REPORTED THE PHYSICIAN SELECTED A GORE? VIATORR? TIPS ENDOPROSTHESIS FOR A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. THE DEVICE WAS ADVANCED AND PLACED IN THE DESIRED LOCATION. TWO THIRDS OF THE DEVICE WAS DEPLOYED WHEN THE DEPLOYMENT LINE BECAME STUCK AND FULL DEPLOYMENT COULD NOT BE COMPLETED. THE PHYSICIAN MADE MULTIPLE ATTEMPTS TO COMPLETE DEPLOYMENT USING ENDOVASCULAR TECHNIQUES, BUT WAS UNSUCCESSFUL. A DIRECT PORTAL STICK WAS PERFORMED AND A SNARE WAS USED TO CAPTURE THE END OF THE GUIDEWIRE IN ATTEMPT TO BETTER MANEUVER THE STENT/DEPLOYMENT LINE. DEPLOYMENT WAS AGAIN ATTEMPTED; HOWEVER, THE DEPLOYMENT LINE BROKE ALONG WITH APPROXIMATELY 10-12CM OF THE DELIVERY CATHETER. A 16FR SHEATH WAS INTRODUCED AND THE DELIVERY CATHETER FRAGMENT WAS SNARED FROM THE PATIENT. A 5MM BALLOON WAS THEN ADVANCED AND DEPLOYED INSIDE THE STENT IN AN ATTEMPT TO COMPLETE DEPLOYMENT, BUT THE BALLOON BROKE AND WAS REMOVED. A NON-COMPLIANT BALLOON WAS THEN ADVANCED AND DEPLOYED; THE STENT OPENED COMPLETELY AND REMAINS IMPLANTED. THERE WERE NO REPORTED ADVERSE EFFECTS FOR THE PATIENT.