MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,07 report with the FDA on 2014-05-29 for COSGROVE-EDWARDS ANNULOPLASTY SYSTEM 1150 manufactured by Edwards Lifesciences.
[11938770]
Additional manufacturer narrative: a model 1150 handle and annuloplasty ring holder were returned and evaluated by engineering. As reported, the customer connected the ring holder to its handle in order to start passing the sutures through the ring as per procedure. When passing the first suture, the connection between the handle and the ring holder broke and the suturing and parachuting could not be completed. As received, the snap assembly of the model 1150 handle was broken off. The broken piece was approximately 7mm in length and appeared to match up to the handle end. The malleable part of the handle was bent slightly. Root cause analysis: based on the evaluation done by engineering, the root cause of the snap assembly breaking could not be conclusively determined; however, it is likely due to the handling of the device. The retaining sutures connecting the template and lanyard assembly appeared to be loose. The loose connection suggests a large amount of force was used when implanting the device. It is unlikely the sutures were loose prior to implanting the device because there is a 100 percent visual inspection to verify the correct cartridge attachment is seated against the template per procedure. It is possible this large force caused the snap assembly to break. The model 1150 handle is designed to be reusable and the snap-fit insertion and removal force be between 600 grams and 3500 grams after 30 sterilization cycles. Corrective action: based on the available information, no corrective action will be taken as this event does not appear to be manufacturing related. There were no report of particles coming into contact with the patient and the broken piece appeared to match with the handle. A review of complaints for the model 1150 handle for the past 2 years was conducted, and there appears to be one similar event in which the snap assembly of an 1150 handle broke. However, it occurred prior to use being introduced to the patient. The instructions for use (ifu) state the model 1150 handle may be utilized in conjunction with the holder to facilitate ease of suture placement and implantation. Insertion of the mitral prosthesis may be accomplished with the handle and holder, with the holder alone, or without either holder or handle.
Patient Sequence No: 1, Text Type: N, H10
[16775804]
Reportedly, the re-usable handle to an annuloplasty ring broke after it had been attached to the ring template. No pieces fell into the patient and another ring was chosen and implanted without issue. As reported, the device was chosen after sizing and selection of appropriate ring to implant. They opened the box, they opened the internal blister and they connected the ring holder to its handle in order to start passing the sutures through the ring, as per procedure. When passing the first suture, the connection between the handle and the ring holder broke not allowing anymore to complete ring suturing and parachuting. Another ring same model and size was implanted in replacement.
Patient Sequence No: 1, Text Type: D, B5
[17094465]
Customer report of broken handle was confirmed. As received, connection point of handle was broken off, broken piece was approx 7mm in length. Broken piece appeared to match up with handle end. As received, malleable part of handle was bent slightly. Additional follow up was requested for additional information regarding the length of time this device has been in service, maintenance information, and number of times sterilized. Because this is not a serialized device, we are unable to perform a device history record (dhr) review. However, the device is currently under review with research and development. Our findings will be reported upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2015691-2014-01253 |
| MDR Report Key | 3839468 |
| Report Source | 01,06,07 |
| Date Received | 2014-05-29 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-03-27 |
| Date Mfgr Received | 2014-07-28 |
| Date Added to Maude | 2014-07-02 |
| 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 | 0 |
| Manufacturer Contact | MR. NEIL LANDRY |
| Manufacturer Street | 1 EDWARDS WAY 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 | COSGROVE-EDWARDS ANNULOPLASTY SYSTEM |
| Generic Name | HANDLE, SCALPEL |
| Product Code | GDZ |
| Date Received | 2014-05-29 |
| Returned To Mfg | 2014-05-02 |
| Model Number | 1150 |
| 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 | 2014-05-29 |