MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-26 for PERCEVAL SUTURELESS AORTIC HEART VALVE TBD manufactured by Livanova Canada Corp.
[185510327]
Given that the device was not returned and the serial number not provided, no investigation is possible at this time. As such, the root cause of the reported event cannot be definitively stated. It should be noted that endocarditis is listed as a possible adverse event in the perceval ifu. The event is, therefore, a known inherent risk of the device. The manufacturer is following up to retrieve additional details on the event and on the device. Should further information be received, a follow-up report will be provided. Retained at the hospital.
Patient Sequence No: 1, Text Type: N, H10
[185510328]
A patient received a perceval valve during the week of (b)(6) 2020. During the week of 17 feb 2020, a patient presented at the hospital with severe temperature. Echo revealed inflammation of the heart but not yet on the valve prosthesis and they decided for treatment with antibiotics. A week later, the echo showed a clear thickening of the valve and severe septal inflammation. In the meantime, the patient suffered from renal insufficiency. The patient was referred for immediate cardiac surgery due to severe endocarditis. The perceval valve was removed and replaced by a crown 25 and mvalsalva conduit 30mm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004478276-2020-00143 |
| MDR Report Key | 9887175 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-25 |
| Date Mfgr Received | 2020-02-28 |
| Date Added to Maude | 2020-03-26 |
| 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 | MS FRANCESCA CROVATO |
| Manufacturer Street | 5005 NORTH FRASER WAY |
| Manufacturer City | BURNABY, BRITISH COLUMBIA V5J 5M1 |
| Manufacturer Country | CA |
| Manufacturer Postal | V5J 5M1 |
| Manufacturer G1 | LIVANOVA CANADA CORP |
| Manufacturer Street | 5005 NORTH FRASER WAY |
| Manufacturer City | BURNABY, BRITISH COLUMBIA V5J 5M1 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | V5J 5M1 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCEVAL SUTURELESS AORTIC HEART VALVE |
| Generic Name | TISSUE HEART VALVES |
| Product Code | LWR |
| Date Received | 2020-03-26 |
| Model Number | TBD |
| Catalog Number | TBD |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIVANOVA CANADA CORP |
| Manufacturer Address | 5005 NORTH FRASER WAY BURNABY, BRITISH COLUMBIA V5J 5M1 CA V5J 5M1 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-26 |