MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER; SIZER, HEART-VALVE, PROSTHESIS

Model Number 1133

Device Problem Fracture (1260)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2014

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: as received, the barrel end of the sizer was completely detached from the metal rod of the handle.Multiple cracks were noticed at the overmold section of the barrel.An area of the overmold section, between the cracks, had fell off.Most of the broken piece was missing and not returned except one fragment which was triangular in shape and approximately 5mmx5mmx4mm in size.Multiples cracks were also found at the overmold section of the replica end of the sizer.One plastic fragment had came off the overmold section and was missing from the sizer.The missing fragment was not returned.Multiple crazing marks were also evident on the replica end.Both cracked barrel and replica ends appeared opaque compared to lab samples.Results: sizer.Additional manufacturer narrative: handles and sizers are re-usable instruments that are re-sterilized after each use.They are often used until visible damage is detected.They are typically inspected by the operative team during cleaning and prior to packaging for re-sterilization and fractures can be visually detected.The majority of fragments or fractures are found during routine handling of the devices outside of valve implantation.As instructed in our ifu, these devices should typically be inspected by the operative team after these cycles and prior to use.In this case, customer report of piece of plastic from fell off the sizer was confirmed.The response from the health care provider indicated that it could not been determined how many times this device was used and sterilized.Repeated use of this device most likely contributed to the failure of the sizer.However, specific number of times used cannot be determined.

Manufacturer Narrative

Evaluation summary (updated): a model 1133 19mm sizer was returned and evaluated by engineering.As reported, a small piece of plastic detached from the sizer and fell into the left ventricular cavity of the patient.The piece was found and removed, and the patient¿s left ventricular cavity and chamber were carefully inspected and no other fragments were noticed.The estimated number of uses/sterilization cycles was 50-60.Cleaning and sterilization methods used was water (90 degrees c), steamed washing (134 degrees c), and proteozin processing.As received, the barrel end of the sizer was completely detached from the metal rod of the handle.Multiple cracks were noticed at the overmold section of the barrel.An area of the overmold section, between the cracks, had fallen off.Most of the broken piece was missing and not returned except one fragment which was triangular in shape and approximately 5x5x4mm in size.Multiple cracks were also found at the overmold section of the replica end of the sizer.One plastic fragment had come off the overmold section and was missing from the replica end of the sizer.This missing fragment was not returned.Multiple crazing marks were also evident on the replica end.Both cracked barrel and replica ends appeared opaque compared to lab samples.Additionally, the replica end was whitish in color compared to the barrel end.Based on the evaluation done by engineering, the root cause of the cracks and fracture are likely due to excessive wear and sterilizations.It also appears the sizer in the event is prior to corrective action.The sizers manufactured pre-capa have a clear, light yellow appearance on the barrel and replica ends while the sizers manufactured post-capa have a clear, darker yellow appearance and also have a lot number on the handle.Per the capa, new material was implemented which provided higher temperature resistance, greater chemical resistance, and greater steam sterilization stability compared to the previous material.The lot number on this sizer is unavailable, therefore the dhr could not be reviewed.A capa was initiated to address the sizer fractures in the magna and magna ease sizers.As a result of the capa, a new design to the 1130 and 1133 sizers was implemented.In this event, the piece that broke off into the patient was found and removed.Cracking and damages are expected after repeated uses and sterilizations.The instructions for use (ifu) state that sizers should be examined for signs of wear, such as dullness, cracking or crazing and should be replaced if any deterioration is observed prior to each use.Recommended cleaning and sterilization conditions are also included in the ifu.

Event Description

Edwards received notification that a small piece of plastic of about 3mm detached from the sizer and fell into the left ventricular cavity of the patient.The piece was found and removed.The patient's left ventricular cavity and chamber were carefully inspected with the aid of a video camera with no other findings.The edwards valve was implanted and patient post-operative course is noted as normal.The device will be retained by the hospital for 1 (one) month for examination and for internal tests.After this period, it will be available for return and examination.

Manufacturer Narrative

Method: device not returned.This is not a serialized device; therefore, the device history record (dhr) review cannot be done.Although these devices are reusable, they do not have an indefinite shelf life.According to the directions in the instructions for use (ifu) supplied with the accessories, sizers and sizer handles must be disassembled before re-sterilization.The accessories should be examined for signs of wear, such as dullness, cracking, or crazing, and do not use if deterioration is observed.In this case, the maintenance and usage information has been requested but not received.The device has not been returned for evaluation.Therefore, we cannot confirm the clinical report or investigate further into the root cause for fracture of this device.

• Brand Name: CARPENTIER-EDWARDS AORTIC ANNULOPLASTY VALVE SIZER
• Type of Device: SIZER, HEART-VALVE, PROSTHESIS
• 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; m/s lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 4295832
• MDR Text Key: 12736925
• Report Number: 2015691-2014-02862
• Device Sequence Number: 1
• Product Code: DTI
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention