MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-26 for GORE VIATORR? TIPS ENDOPROSTHESIS manufactured by W.l. Gore & Associates.
[112368885]
(b)(4). The article stated the average age for group a was 63. 6, therefore 64 will be used for patient age. The article stated that for group a 75% were female, therefore female will be used as patient gender. Patient weight requested but not provided. Date of death requested but not provided. Date of event used is the date article published, (b)(6) 2018. As exact date is unknown, (b)(6) 2018 will be used. Modha k, kapoor b, lopez r, sands m, and carey w. Symptomatic heart failure after transjugular intrahepatic portosystemic shunt placement: incidence, outcomes, and predictors. Cardiovasc intervent radiol (2018) 41:564? 571.
Patient Sequence No: 1, Text Type: N, H10
[112368886]
This information was received through literature article "symptomatic heart failure after transjugular intrahepatic portosystemic shunt placement: incidence, outcomes, and predictors" published in cardiovascular interventional radiology: april 2018 the articles objective is to assess the incidence of symptomatic heart failure (shf) occurring after transjugular intrahepatic portosystemic shunt (tips) placement, identify potential predictors of shf, and evaluate clinical presentation and outcomes in cases of post-tips shf. Shf was defined as otherwise unexplained new-onset dyspnea, hypoxemia (oxygen saturation of <92 mm hg on pulse oximetry or arterial partial pressure of oxygen <80 mm hg), radiologic pulmonary edema, new/increased need for diuretics, and/or need for intubation within 7 days of tips placement. The article reports that a prospectively maintained tips database was used to identify patients who underwent new tips placements at a large urban tertiary care center between 1995 and 2014. A total of 882 patients were in the final study group. The article reports that eight patients (0. 9%) developed shf, usually manifested by hypoxemia (50%) or dyspnea (25%) within 48 hours. Of the eight patients, one death occurred on day 12 after tips placement as a result of persistent hypoxia, renal failure, and worsening encephalopathy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007284313-2018-00190 |
| MDR Report Key | 7638930 |
| Date Received | 2018-06-26 |
| Date of Report | 2018-06-07 |
| Date of Event | 2018-04-01 |
| Date Added to Maude | 2018-06-26 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | KATHY TITUS |
| 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 | 2018-06-26 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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. Death | 2018-06-26 |