MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER; ANNULOPLASTY RING SIZER

Model Number 1150

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Date 10/03/2014

Event Type  Injury  

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint".The information reported may or may not be related to the edwards device.In this case, edwards received information that during implantation of an annuloplasty ring, the surgeon broke the handle through "improper use" and not due to a manufacturing defect.According to the operating room, the surgeon held the handle "somewhere" and as the surgeon was placing the ring, the handle broke.The handle and ring were discarded.

Manufacturer Narrative

Device not returned.The annuloplasty ring sizer was not returned to edwards for analysis because it was discarded at the hospital.Without return of the device, edwards is unable to conclusively determine the root cause for this event.The site indicated the breakage of the handle was not due to a device malfunction, but due to technical error; as well, there was no report of patient injury as a result of this breakage.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.

• Brand Name: CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER
• Type of Device: ANNULOPLASTY RING SIZER
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4237991
• MDR Text Key: 15813564
• Report Number: 2015691-2014-02642
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 81 YR