HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Adverse Event — Malfunction (MDR 2916596-2020-02084)
HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM Adverse Event — Malfunction (MDR 2916596-2020-02084) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM; Generic name: VENTRICULAR (ASSISST) BYPASS; Manufacturer: THORATEC CORPORATION.
| Device | HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM |
|---|---|
| Generic name | VENTRICULAR (ASSISST) BYPASS |
| Manufacturer | THORATEC CORPORATION |
| Report number | 2916596-2020-02084 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THE HEARTMATE 3 LVAS WAS IMPLANTED DURING THE (B)(6) CLINICAL TRIAL, IDE# (B)(4). FDA APPROVAL FOR HEARTMATE 3 LVAS WAS RECEIVED ON 23 AUGUST 2017. THE GTIN UNIQUE DEVICE IDENTIFIER FOR THE COMMERCIAL HEARTMATE3 LVAS IS (B)(4). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. |
| Source | openFDA MAUDE (device adverse events) |
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