MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COSGROVE-EDWARDS ANNULOPLASTY SYSTEM; RING, ANNULOPLASTY

Model Number 4600

Device Problems Inadequacy of Device Shape and/or Size (1583); Device Markings/Labelling Problem (2911)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to edwards for evaluation as it remains implanted.The device history record (dhr) was reviewed and shows that this device met all manufacturing specifications for product release prior to distribution.No issues were identified that would have impacted this event.In this case, the size and serial number of the ring were incorrect on the sticker inside the box.A definitive root cause could not be determined.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

As reported, size and serial number of this ring indicated on the box did no match with the size and serial number indicated on the sticker inside the box.The issue was observed during preparation of a mitral valve repair.The device was implanted with no consequences for the patient who was noted to be hospitalized in stable condition after the procedure.

Event Description

As reported, size and serial number of this ring model indicated on the box (32mm) did not match with the size and serial number indicated on the sticker inside the box (28mm).The issue was observed during preparation of a mitral valve repair.The surgeon wanted 32mm so they opened the 32mm but after the surgery, they have found the insert paper for patient indication sticker was indicated 28mm.The device was implanted with no consequences for the patient who was noted to be hospitalized in stable condition after the procedure.

Manufacturer Narrative

Customer report of size and serial number on the shelf box was different than the size and serial number on the implant card was confirmed through image evaluation.Evaluation was performed through six color pictures provided by the customer.The images included two pictures of the shelf box, one picture of the id tag, and three pictures of the implant card.The shelf box and id tag print was for size 32mm.The implant card print was for size 28mm.

Manufacturer Narrative

Most labeling issues have little potential for patient injury, such as incorrect lot number or typographical error.Exceptions may include those that have errors in the size of the device or shelf-life of the product.These complaints should be assessed on an individual basis based the actual non-conformance.In this case, it was initially reported that the size and serial number of the ring were incorrect on the inside sticker box, through investigation and engineering evaluation it was confirmed that the size and sn on the box and label were correct and the implant data card was incorrect.The device remains implanted and the patient status is stable.Per the engineering evaluation, this issue is a confirmed labelling defect because the images provided show that the idc indicates the device is a different size and serial number than the size and serial number on the id tag and shelf box.A root cause has not been determined at this time, but the issue will be investigated under capa and scar.An awareness communication has been performed.

Manufacturer Narrative

H11: corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: COSGROVE-EDWARDS ANNULOPLASTY SYSTEM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8130312
• MDR Text Key: 130329770
• Report Number: 2015691-2018-05055
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K923367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR