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 2020-03-18 for CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL CPHV M7-031 manufactured by Sorin Group Italia S.r.l..
[184316403]
A complete manufacturing and material records review for the device has been performed. The results confirmed that the device satisfied all material, visual and performance standards required at the time of manufacture and release.
Patient Sequence No: 1, Text Type: N, H10
[184316404]
On (b)(6) 2005 a patient received a carbomedics standard m7-031 mitral valve as part of an mvr. The manufacturer was notified that the device was explanted on (b)(6) 2020 and an abbott epic vale was implanted as a replacement. A concomitant tricuspid valvuloplasty was performed. Additional information was received from the site on mar. 16, 2020 identifying the following. The abbott valve was a size 29mm. Patient is still in the general ward but vale functionality of replacement is good. The reason for explant was the opening motion of one leaflet was not good. There was no problem at the implantation and extraction of the carbomedics valve. No imaging and no further information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005687633-2020-00107 |
| MDR Report Key | 9851235 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-18 |
| Date of Report | 2020-03-18 |
| Date of Event | 2020-02-19 |
| Date Mfgr Received | 2020-02-19 |
| Date Added to Maude | 2020-03-18 |
| 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 | FRANCESCA CROVATO |
| Manufacturer Street | 5005 N FRASER WAY |
| Manufacturer City | BURNABY, BC V5J 5M1 |
| Manufacturer Country | CA |
| Manufacturer Postal | V5J 5M1 |
| Manufacturer G1 | SORIN GROUP ITALIA S.R.L. |
| Manufacturer Street | STRADA CRESCENTINO SNC |
| Manufacturer City | SALUGGIA, VC 13040 |
| Manufacturer Country | IT |
| Manufacturer Postal Code | 13040 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARBOMEDICS STANDARD PROSTHETIC HEART VALVE, MITRAL |
| Generic Name | MECHANICAL HEART VALVE PROSTHESIS |
| Product Code | LWQ |
| Date Received | 2020-03-18 |
| Returned To Mfg | 2020-02-28 |
| Model Number | CPHV |
| Catalog Number | M7-031 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SORIN GROUP ITALIA S.R.L. |
| Manufacturer Address | STRADA CRESCENTINO SNC SALUGGIA, VC 13040 IT 13040 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-18 |