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 2013-07-24 for CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER 1161 manufactured by Edwards Lifesciences.
[11031714]
Evaluation summary attached: customer report of chipped sizer could not be confirmed, due to affected sizer was discarded per customer report. However, example sizer set was also found to have one chipped sizer. See attached e-mail. All 7 sizers appeared white and opaque in color and had a slightly abrasive surface. As received, 29mm sizer had a chip approx 8mm in length. Chipped piece was not returned with the sizers. Remaining 6 sizers did not appear chipped but shaved in certain areas. Affected device not returned. Representative device and sketch of device used for initial evaluation.
Patient Sequence No: 1, Text Type: N, H10
[18410505]
Evaluation summary attached: customer report of chipped sizer was confirmed. All 7 sizers appeared white and opaque in color and had a slightly abrasive surface. As received, 29mm sizer had a chip approx 8mm in length. Chipped piece was not returned with the sizers. Remaining 6 sizers did not appear chipped but shaved in certain areas. Sketch of sizer provided by customer was consistent with lab findings.
Patient Sequence No: 1, Text Type: N, H10
[18855060]
The hospital contact relayed the following information to the sales rep in a meeting. Reportedly, during sizing for implant of an aortic valve, a small part/chip of the green sizer fell into the ventricle. The broken piece was retrieved from the ventricle and the valve was implanted without issue. The patient is doing well. The doctor believes that the sizer became brittle due to numerous sterilizations.
Patient Sequence No: 1, Text Type: D, B5
[19217283]
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 hospital has a high volume of sizer sets. As they are lost sometimes and are replaced individually with wear, the age of the broken sizer is unknown. As a preventative measure, the sales rep will now replace all perimount sizers at the hospital. This is not a serialized device and there is no lot number available; therefore, no device history record (dhr) review can be done. The date of event is unknown. The length of time this size 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 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. 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
[19793594]
Additional manufacturer narrative: the damaged 1161 sizer was not returned for evaluation; however, 7 sizers ranging from size 19mm to 31mm of the same model were returned by the customer. Based on a visual observation of all 7 sizers, there appears to be evidence of wear that would normally occur after many cleaning and sterilization cycles. All 7 sizers were observed to have areas of dullness. It was also noted all the sizers exhibited areas that were whitish and opaque in color. Finally, areas of crazing were noted in the 31mm sizer. As received, 1 sizer (29mm) had a chip on the sizer lip that measures approximately 8mm in length. The chipped piece was not returned with the sizers. None of the remaining 6 sizers appeared chipped but the surfaces were dull and abrasive instead of shiny and smooth in appearance. The customer was interviewed regarding cleaning, sterilization cycles and detergent use. It was reported by the customer the sizers undergo routine pre-rinse and cleaning with steam and an enzymatic cleaner, name unknown. The temperature and duration of cleaning and sterilization cycles were also provided. It? S indicated the cleaning cycle was performed at 93 degrees celsius for 3 minutes and the sterilization cycle is performed at 121 degrees celsius for 17 minutes. It? S noted the parameters for sterilization are different than the recommended parameters in the ifu. Ultimately, the hospital is responsible for the qualification of any deviations from the recommended method of cleaning or sterilization. The age and number of use cycles for the returned sizers is unknown. The appearance of these returned sizers is typical and would be expected for sizers undergoing a normal wear/deterioration after exposure to a large number of cleaning and sterilization cycles. The rate of this deterioration can be affected by the type of cleaning solutions used and the parameters of cleaning and sterilization. The instructions for use cautions the user to inspect the sizers prior to use for signs of wear, such as dullness, cracking or crazing and cautions the user to replace sizers showing any deterioration. It appears the customer has been ineffectively assessing the suitability of the sizers for use as dullness and crazing were observed in the sizers returned for evaluation. The edwards sales representative reported performing retraining the hospital staff to check the sizers for dullness and cracks before use and when not to use sizers showing signs of deterioration. It? S also reported the staff know how to obtain new replacement sizers when needed. Replacement of an indeterminate number of 1161 sizers was performed. No additional corrective action will be taken at this time as the failure appears to be the result of failure to replace sizers exhibiting signs of deterioration most likely caused by excessive use. In this event all components which broke off the sizer were reportedly retrieved and there have been no adverse effects reported for the patient.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2013-20676 |
| MDR Report Key | 3246317 |
| Report Source | 01,05,06,07 |
| Date Received | 2013-07-24 |
| Date of Report | 2013-06-26 |
| Date of Event | 2013-06-26 |
| Date Mfgr Received | 2013-09-25 |
| Date Added to Maude | 2013-10-22 |
| 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 | CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER |
| Generic Name | SIZER, HEART-VALVE, PROSTHESIS |
| Product Code | DTI |
| Date Received | 2013-07-24 |
| Returned To Mfg | 2013-08-29 |
| Model Number | 1161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2013-07-24 |