MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2015-06-12 for 1133 manufactured by Edwards Lifesciences.
[6193478]
Additional information received indicates the reported sizer was discarded. The patient tolerated the procedure well with no reported complications.
Patient Sequence No: 1, Text Type: D, B5
[19505364]
Edwards learned of a sizer that broke off into several pieces as the surgeon was sizing and pulled the sizer from the annulus. There were no reported complications or injury to the patient. Attempts to obtain additional information and explanted device have been unsuccessful.
Patient Sequence No: 1, Text Type: D, B5
[19622700]
Additional manufacturer narrative - the reported device was not returned to manufacturer. Without receipt of the explanted device the reported clinical observation cannot be confirmed. Edwards will continue to review and monitor all events. Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2015-01390 |
| MDR Report Key | 4842117 |
| Report Source | 05,06 |
| Date Received | 2015-06-12 |
| Date of Report | 2015-05-15 |
| Date of Event | 2014-12-02 |
| Date Mfgr Received | 2015-05-15 |
| Date Added to Maude | 2015-06-12 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | ONE EDWARDS WAY MS: LFS 33 |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502289 |
| Manufacturer G1 | EDWARDS LIFESCIENCES LLC |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2015-06-12 |
| Model Number | 1133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | ONE EDWARDS WAY IRVINE CA 92614 US 92614 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-12 |