MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,study report with the FDA on 2020-03-30 for HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM 106524 manufactured by Thoratec Corporation.
[185577570]
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 same device is used commercially and in the ongoing (b)(6) trial. 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.
Patient Sequence No: 1, Text Type: N, H10
[185577571]
It was reported by the vad coordinator that the patient expired due to right heart failure and multifocal pneumonia leading to hypoxic respiratory failure. It was reported the device operated as intended without issues or malfunctions that would have contributed to the patient's death. The device was not returned for evaluation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01717 |
| MDR Report Key | 9899257 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-18 |
| Date Mfgr Received | 2020-03-20 |
| Device Manufacturer Date | 2017-04-06 |
| Date Added to Maude | 2020-03-30 |
| 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 | MR. BOB FRYC |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528204 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 95488 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95488 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM |
| Generic Name | VENTRICULAR (ASSISST) BYPASS |
| Product Code | DSQ |
| Date Received | 2020-03-30 |
| Model Number | 106524 |
| Lot Number | 5956201 |
| Device Expiration Date | 2019-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | 6035 STONERIDGE DRIVE PLEASANTON CA 95488 US 95488 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death; 2. Hospitalization; 3. Required No Informationntervention | 2020-03-30 |