MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2013-08-22 for PERIMOUNT MAGNA EASE SIZER 1133 manufactured by Edwards Lifesciences.
[3712009]
As reported by the hospital contact to the sales rep, the surgeon inserted the sizer in the patient's aortic annulus to measure and the sizer broke in several pieces which fell into the patient's ventricle. The surgeon was able to recover the broken pieces and verified that nothing was missing to the broken sizer by putting the pieces together again. The procedure went well and the patient recovered well. The surgeon was suspecting that the sizer was worn out and may have been sterilized too many times. The broken sizer was not kept, therefore it will not be returned.
Patient Sequence No: 1, Text Type: D, B5
[11020493]
Method: device not returned. The sizer is no longer available for return and evaluation as it was discarded at the hospital. Therefore, we are unable to confirm the event and to determine root cause for the reported break. This is not a serialized device and there is no lot number available; therefore, no device history record (dhr) review can be done. The length of time this sizer has been in use and the number of times this device has been cleaned and sterilized remains unknown. It is also unknown what cleaning and sterilization parameters or additives were used on this device. This information has been requested but has not been provided. The sales rep reiterated to the surgeon that they should inspect the accessories regularly for signs of wear and tear and should not hesitate to request a new set if the sizers are showing signs of deterioration. This is also mentioned in every operating room nurse training. Per 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. " it is assumed this event occurred because the device was not taken out of service when inspected as recommended by the ifu. However, without return of the device and/or answers to our questions, we are unable to conclusively determine root cause for the fracture of this device. If new information is received, a follow up report will be submitted.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2013-20884 |
| MDR Report Key | 3304256 |
| Report Source | 01,05,06 |
| Date Received | 2013-08-22 |
| Date of Report | 2013-07-25 |
| Date of Event | 2013-05-01 |
| Date Mfgr Received | 2013-07-25 |
| Date Added to Maude | 2013-11-19 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | 1 EDWARDS WAY MS: PRT 46 |
| 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 | PERIMOUNT MAGNA EASE SIZER |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2013-08-22 |
| Model Number | 1133 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 | 2013-08-22 |