MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,litera report with the FDA on 2018-01-22 for GORE? VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[97905561]
Citation: yoeli d, galv? N ntn, ashton dj, et al. Portosystemic shunt as a bridge to liver transplantation in infants: a comparison of two techniques. Pediatr transplant. 2017;21:e12915. Https://doi. Org/10. 1111/petr. 12915 (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[97905562]
This information was received through literature article "portosystemic shunt as a bridge to liver transplantation in infants: a comparison of two techniques" published in pediatric transplantation, (b)(6) 2017. The case study reports a (b)(6) male infant with end-stage liver disease secondary to unrepaired biliary atresia presented with massive gastrointestinal bleeding due to variceal rupture and severe coagulopathy. His hemoglobin, platelets, and inr were 3. 5 g/dl, 17 000/l, and 4. 8, respectively, requiring transfusion with 1935 ml of blood products. Control of the bleeding was temporarily achieved with sclerotherapy and balloon tamponade. He was taken to interventional radiology for emergent portosystemic shunt creation using a gore? Viatorr? Tips endoprosthesis. Due to the small size of the patient, the stent extended from the left hepatic vein into the ivc and from the intrahepatic left portal vein into the extrahepatic portal vein. Tips creation was successful at lowering the portosystemic pressure gradient from 38 mm hg to 4 mm hg. Due to the small size of the patient, the 7-cm stent placed for tips extended into the extrahepatic portal vein, as well as into the confluence of the left hepatic vein with the ivc. The patient did not suffer any further episodes of variceal bleeding, although he developed hyperammonemia associated with increased agitation. The hyperammonemia was managed with combinations of continuous renal replacement therapy, molecular adsorbent recirculating system? , and lactulose retention enema. The patient underwent cadaveric whole liver transplantation with bicaval replacement 23 days after tips creation. He tolerated the procedure well and was discharged with good graft function 2 months after transplantation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00028 |
| MDR Report Key | 7210007 |
| Report Source | COMPANY REPRESENTATIVE,LITERA |
| Date Received | 2018-01-22 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-06-01 |
| Date Added to Maude | 2018-01-22 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MARCI STEWART |
| Manufacturer Street | 1500 N. 4TH STREET |
| Manufacturer City | FLAGSTAFF AZ |
| Manufacturer Phone | 9285263030 |
| Manufacturer G1 | MEDICAL PHOENIX 1 B/P |
| Manufacturer Street | 32360 N. NORTH VALLEY PARKWAY |
| Manufacturer City | PHOENIX AZ 85085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 85085 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GORE? VIATORR? TIPS ENDOPROSTHESIS |
| Generic Name | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS |
| Product Code | MIR |
| Date Received | 2018-01-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | W.L. GORE & ASSOCIATES |
| Manufacturer Address | FLAGSTAFF AZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2018-01-22 |