MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2017-12-06 for THORATEC CENTRIMAG RVAS 201-90001 manufactured by Thoratec Switzerland Gmbh.
[93808548]
The lot number of the device was not provided, therefore the expiration date, manufacture date and device unique identifier (udi) are unknown. Approximate age of device? 4 days. The information regarding the patient''s outcome associated with the durable lvad device occurred when the lvad was under investigational device exemption. This event captures the thrombus extraction on the right ventricular assist device. The event occurred at (b)(6). 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
[93808549]
It was reported that at the time of implant of a left ventricular assist device (lvad) on (b)(6) 2016, the patient required the placement of extracorporeal right heart support due to biventricular failure. Pre-implant, the patient had been on veno-arterial extracorporeal membrane oxygenation (va ecmo) due to cardiogenic shock. On post-lvad implant day 4, the patient underwent a surgical procedure for thrombotic mass extraction in the right ventricle and a new right sided blood pump circuit was placed. A specific cause for the thrombotic mass in the right ventricle was unknown. The extracorporeal circuit supporting the right ventricle reportedly functioned as intended and was only exchanged due to a change in the cannulation sites. After several attempts to wean the patient, the right ventricular extracorporeal support was discontinued on (b)(6) 2016. The patient also experienced infection of unknown origin in the postoperative phase. The patient was subsequently discharged home on lvad support. On (b)(6) 2017, the patient was admitted to the hospital with left side hemiplegia. The symptoms reportedly started the day before; however, the patient did not immediately present to the hospital. At the time of the event, the patient was being medically managed with anticoagulant therapy (warfarin). The diagnosis was an ischemic stroke with persistent left side hemiplegia. Unspecified,? Conservative therapy? Was provided. The patient then developed hematuria with alteration of liver enzymes and plasma free hemoglobin levels. On (b)(6) 2017, the patient? S laboratory values were: lactate dehydrogenase was above the cut off and could no longer be measured, plasma-free hemoglobin was 304 mg/dl, and the hemoglobin was 10. 2 g/dl. A trans-thoracic echocardiogram found the left ventricle was not unloading properly. An lvad pump exchange was scheduled for the following day; however, the patient's condition rapidly deteriorated and va ecmo was initiated. Despite va ecmo and full inotropic support, the patient expired on (b)(6) 2017 due to multiorgan failure. No further information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2017-03066 |
| MDR Report Key | 7085874 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2017-12-06 |
| Date of Report | 2018-04-06 |
| Date of Event | 2016-08-30 |
| Date Mfgr Received | 2018-03-14 |
| Date Added to Maude | 2017-12-06 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. BOB FRYC |
| Manufacturer Street | 6101 STONERIDGE DR. |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal | 94588 |
| Manufacturer Phone | 7818528390 |
| Manufacturer G1 | THORATEC CORPORATION |
| Manufacturer Street | 6035 STONERIDGE DRIVE |
| Manufacturer City | PLEASANTON CA 94588 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94588 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | THORATEC CENTRIMAG RVAS |
| Generic Name | RIGHT VENTRICULAR BYPASS (ASSIST) DEVICE |
| Product Code | OJE |
| Date Received | 2017-12-06 |
| Model Number | 201-90001 |
| Catalog Number | 201-90001 |
| ID Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC SWITZERLAND GMBH |
| Manufacturer Address | TECHNOPARKSTRASSE 1 ZURICH, CH-8005 SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2017-12-06 |