MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2013-10-11 for TRUE-SIZE OBTURATOR [AORTIC] 1161 manufactured by Edwards Lifesciences.
[17346586]
As reported, a 25mm 1161 sizer head broke during implantation. Due to a previous sizer breakage in this hospital (see mdr 2015691-2013-20676) all model 1161 sizers were reportedly replaced. However, it appears there were a number of sizer sets that were missed. One of the sizer sets was used in a recent procedure. Two sizer heads from the same sizer set broke during the same implantation (same patient). While the doctor measured the annulus with the 25mm and then the 27mm sizers, on each sizer head a chip broke off while sizing the annulus. A piece of the sizer ended up in the main stem but was retrieved and the patient was not affected by this. Through follow up by sales, the message has been reinforced to the doctors and staff at the hospital not to use sizers that become dull or with cracks. The sizer set are being returned for evaluation. All additional sizer sets have been retrieved and are being returned.
Patient Sequence No: 1, Text Type: D, B5
[17363251]
Method: device not received. Conclusion: device evaluation anticipated but not yet begun. The device history record review (dhr) cannot be done because this is not a serialized device. A related device from the same facility was previously reported on mdr #2015691-2013-20676. The product instructions for use (ifu) list time and temperature guidelines as well as equipment and solution recommendations for by hand and by machine cleaning and sterilization. Included in the ifu is the following statement: "caution: examine sizers and handles for signs of wear, such as dullness, cracking or crazing. Replace sizer/handle if any deterioration is observed. " this inspection is done prior to cleaning and sterilization and should prevent breakages during use. The sales rep has been asked to follow up with the hospital to ensure that this is being done on a regular basis. Retraining has been conducted with the staff on proper handling and maintenance of the sizers. All sizer sets have been replaced. There has been no reported event related to injury to a patient regarding use of these sizers. The doctor indicated these events are related to the multiple sterilizations of these devices after lengthy use. The length of time this sizer has been in use and the number of times this device has been cleaned and sterilized remains unknown.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2013-21283 |
| MDR Report Key | 3405551 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-10-11 |
| Date of Report | 2013-09-13 |
| Date of Event | 2013-09-12 |
| Date Facility Aware | 2013-09-12 |
| Date Mfgr Received | 2013-09-13 |
| Date Added to Maude | 2014-01-15 |
| 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 | MR. NEIL LANDRY |
| Manufacturer Street | 1 EDWARDS WAY MAILSTOP: M/S LFS33 |
| 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 |
| Brand Name | TRUE-SIZE OBTURATOR [AORTIC] |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2013-10-11 |
| Returned To Mfg | 2013-09-26 |
| Model Number | 1161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2013-10-11 |