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 2020-03-31 for HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM 106524 manufactured by Thoratec Corporation.
[187040518]
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.
Patient Sequence No: 1, Text Type: N, H10
[187040520]
It was reported that the patient was symptomatic with chest pain and dyspnea on exertion and was found to have a hemoglobin (hgb) concentration of 3. 9 g/dl. The patient was suspected of upper gastrointestinal bleeding, but their colonoscopy and esophagogastroduodenoscopy (egd) results were normal and did not reveal a source of bleeding. The patient was given a blood transfusion of 4 units of packed red blood cells.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01629 |
| MDR Report Key | 9907889 |
| Report Source | HEALTH PROFESSIONAL,STUDY |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-05-04 |
| Date Mfgr Received | 2020-03-18 |
| Device Manufacturer Date | 2017-12-19 |
| 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 | 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 | 2020-03-31 |
| Model Number | 106524 |
| Lot Number | 6256681 |
| Operator | LAY USER/PATIENT |
| 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. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |