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 PVS23 ICV1209 manufactured by Livanova Canada Corp.
[185509465]
On (b)(6) 2020, a perceval implant attempt occurred. The mitral annular curtain, aorta and intra-annular portion are reportedly heavily calcified. The aortic annulus was sized and a perceval medium - pvs23 was selected. The valve collapsing, implant and ballooning were performed uneventfully. Post-implant, the coaptation of leaflets was good, no pinwheeling observed. The visual inspection implied that the pvs23 was correctly deployed and juxtaposed to anatomical structures. After weaning from bypass, the echo showed moderate to high central leak. Consequently, the patient was put back on bypass and the pvs23 was explanted. A decision was made to implant a sutured valve for this patient, who ultimately received an edwards magna ease size 21. It is reported that after the perceval explant, before the sutured valve implant, there was some calcium that was previously unseen that was debrided. The patient remained stable throughout the procedure, with a good outcome after surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004478276-2020-00142 |
| MDR Report Key | 9886290 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-27 |
| Device Manufacturer Date | 2019-10-04 |
| 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 VALVE |
| Product Code | LWR |
| Date Received | 2020-03-26 |
| Model Number | PVS23 |
| Catalog Number | ICV1209 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| 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 |