MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-06-16 for HEARTMATE II manufactured by Thoratec Corporation.
[47815474]
Patient admitted on (b)(6) 2016 for chronic upper sternotomy incision site pain that recently worsened; chest ct unrevealing for infection. However, ldh (659) and plasma free hemoglobin noted to be elevated in setting of inr 2. 0. Last subtherapeutic inr (1. 7) was (b)(6) 2016. On a previous admission, (b)(6) 2016, patient ldh was 633 u/l in setting of a uti. On that admission, patient was treated with heparin, had a decrease in ldh (400's) and discharged on antibiotics and continued regimen of asa and warfarin. On this admission, heparin gtt was started ((b)(6) 2016). Cta of lvad did not reveal thrombus at inflow or outflow cannula, echo also unrevealing. Ldh on (b)(6) was 1039 u/l. Patient restarted on heparin and ct surgery was consulted. Patient developed ha and visual changes (b)(6) 2016. Emergency exchange was pursued due to neurological symptoms and rising ldh despite therapeutic anticoagulation. Thrombus found in inflow bearing on exchange.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5737947 |
| MDR Report Key | 5737947 |
| Date Received | 2016-06-16 |
| Date of Report | 2016-06-15 |
| Date of Event | 2016-06-03 |
| Date Facility Aware | 2016-06-03 |
| Report Date | 2016-06-15 |
| Date Reported to FDA | 2016-06-15 |
| Date Reported to Mfgr | 2016-06-10 |
| Date Added to Maude | 2016-06-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEARTMATE II |
| Generic Name | LEFT VENTRICULAR ASSIST SYSTEM |
| Product Code | OKR |
| Date Received | 2016-06-16 |
| Returned To Mfg | 2016-06-10 |
| Device Availability | N |
| Device Age | 6 MO |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | THORATEC CORPORATION |
| Manufacturer Address | 6035 STONERIDGE DR. PLEASANTON CA 94588 US 94588 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-06-16 |