MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-30 for HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS) 106015 manufactured by Thoratec Corporation.
[186554159]
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
[186554160]
It was reported that on (b)(6) 2020 the patient had low flow alarms. The estimated flow appeared to be below the alarm threshold of 2. 5 lpm. Patient had signs and symptoms of pump thrombosis. Patient had clinical evidence of hemolysis with elevated lactate dehydrogenase (ldh) levels that was fluctuating but up to 900, and failed ramp echo in which left ventricular end diastolic diameter (lvedd) was not properly changing with altered left ventricular assist device (lvad) speeds. Computed tomography angiography (cta), echocardiogram, and transesophageal echocardiography (tee) did not show anything abnormal. Patient hospitalized and on intravenous (iv) heparin which resolved low flows. Clinician believed that clot is perhaps in inflow conduit, outflow elbow of pump, or both, yielding the persistent low flow alarms. Pump exchange of heartmate 2 for heartmate 3 was performed on (b)(6) 2020, and the pump was returned. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01708 |
| MDR Report Key | 9901180 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-13 |
| Date Mfgr Received | 2020-03-13 |
| Device Manufacturer Date | 2018-10-24 |
| 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 II LVAS IMPLANT KIT (WITH SEALED GRAFTS) |
| Generic Name | VENTRICULAR (ASSISST) BYPASS |
| Product Code | DSQ |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-24 |
| Model Number | 106015 |
| Catalog Number | 106015 |
| Lot Number | 6706666 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 | 2020-03-30 |