MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP 1103 manufactured by Heartware, Inc..
[185884297]
This device is used for treatment not diagnosis. The ventricular assist system is indicated for use as a bridge to cardiac trans plantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure. The system is designed for in-hospital and out-of-hospital settings. This information was received from the destination therapy post approval study. Investigation of this event is pending and a supplemental report will be sent upon its completion. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185884298]
It was reported that a ventricular assist device (vad) patient was found unresponsive at home and admitted for a serious hemorrhagic cerebrovascular accident (cva) with a glasgow coma scale of five to six on arrival. A computerized tomography (ct) revealed a right temporal intra-ventricular hemorrhagic stroke with extension into the right subdural space causing a significant herniation. The patient had an international normalized ratio (inr) between two to three. The family decided to inactivate vad support. The patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007042319-2020-02773 |
| MDR Report Key | 9907923 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-22 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2018-12-19 |
| Date Added to Maude | 2020-03-31 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | HEARTWARE, INC. |
| Manufacturer Street | 14400 NW 60TH AVE |
| Manufacturer City | MIAMI LAKES FL 33014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP |
| Generic Name | VENTRICULAR (ASSIST) BYPASS |
| Product Code | DSQ |
| Date Received | 2020-03-31 |
| Model Number | 1103 |
| Catalog Number | 1103 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEARTWARE, INC. |
| Manufacturer Address | 14400 NW 60TH AVE MIAMI LAKES FL 33014 US 33014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-31 |