MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING

Model Number 5200M30

Device Problems Unsealed Device Packaging (1444); Device Damaged Prior to Use (2284); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2018

Event Type  malfunction  

Manufacturer Narrative

Any packaging non-conformance that results in a breach of the sterile package (i.E.Pinhole, tear or seal issue), has the potential to result in a serious infection.In this case, it was reported that during the surgery, the device was reported to be "half-opened." the device is in the process of being returned.The root cause cannot be determined at this time.If new information becomes available or the device history record (dhr) review is completed, a supplemental report will be submitted.

Event Description

Edwards received information that this annuloplasty ring model 30mm was found in a damaged packaging.The issue was detected during the surgery at box opening.As reported, when they opened the first package, they realized that the second one was in poor condition "half-opened." another ring was opened.The patient was reported to be well.

Manufacturer Narrative

As received, and as seen on image provided by the customer, the label on the outer tray tyvek lid was observed to be wrinkled and partially illegible.The outer tray lid was approximately 75% opened.Adhesive/lid residue was observed around the rim of the outer tray.A non-edwards circular tray containing the ring was returned inside the outer tray.The ring was returned with the holder attached and id tag removed.No visible damages were observed on the ring or holder.Suture holes were not visible on the ring.The x-ray demonstrated that the ring remained intact.Both the tyvek label and the shelf box were returned in similar condition as in the images provided by the customer.Per the product evaluation, the customer report of damaged outer tray was confirmed due to damaged tyvek label.Report of outer tray received "half-opened" was confirmed as received.Per the engineering evaluation, during the labelling and packaging process, the outer tray and shelf box are inspected multiple times to ensure there is no damage, and any damage would not pass inspection.It is very unlikely that the outer tray in this condition would have been allowed to leave the warehouse.Also, there is no damage to the shelf box that would imply damage to the sterile barrier of the outer tray occurred during shipping.The images showing the damage and the info gathered by the sales rep implies the shelf box was opened in the operating room, where the outer tray was found damaged.There was no confirmation that the shelf box tamper seal was broken at this time, meaning it may have been broken at an earlier time.The device was shipped to the customer in (b)(6) of 2018 and the occurrence date given for this event was in october of the same year.Although a definitive root cause cannot be determined, it is highly likely that the shelf box and outer tray were opened by the customer during an earlier surgery and were replaced to stock/storage when the device was not needed.An manufacturing/supplier defect was not confirmed.

Manufacturer Narrative

The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8010119
• MDR Text Key: 125300948
• Report Number: 2015691-2018-04397
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2022
• Device Model Number: 5200M30
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention