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.
[186753942]
Manufacturer's investigation conclusion: the pump remains in use supporting the patient. A correlation between the device and the report of gastrointestinal (gi) bleeding could not be conclusively determined. Bleeding is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate ii left ventricular assist system. Gi bleeding has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements. No further information was provided. The manufacturer is closing the file on this event
Patient Sequence No: 1, Text Type: N, H10
[186753943]
It was reported that the patient had a gastrointestinal (gi) bleed and underwent an enteroscopy with capsule placement and an esophagogastroduodenoscopy (egd) (n/a).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2916596-2020-01728 |
| MDR Report Key | 9899313 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2016-06-27 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2015-12-08 |
| 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 |
| Model Number | 106015 |
| Catalog Number | 106015 |
| Device Expiration Date | 2018-10-31 |
| 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 | 2020-03-30 |