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

Model Number	5200M30
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional manufacturer narrative: the investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.
Event or Problem Description
It was reported that a 30mm 5200m mitral ring package was removed from sealed box within the operating room.The outer package was opened in the usual fashion, however, on inspection, the inner package was found peeled back slightly.The ring was not placed on the field as unable to verify the sterility of the inner package.
Additional Manufacturer Narrative
Manufacturer narrative: h3: customer report of open packaging was confirmed.As received, shelf box and tray lid from reported model and sn number.The shelf box was returned unsealed and the packaging outer tray and inner tray seal was partially lifted up from lid with ring inside shelf box.Sn tag was visible through the packaging tray.No visible inconsistencies were observed on the returned ring.Engineering task has been opened and assigned for further investigation.
Event or Problem Description
It was reported that a 30mm 5200m mitral ring package was removed from sealed box within the operating room.The outer package was opened in the usual fashion, however, on inspection, the inner package seal was found partially peeled back.The ring was not used as the implant team was unable to verify it's sterility.Per additional information: the tamper seal on the outer box was not broken.The event happened in the operating room.
Additional Manufacturer Narrative
Updated sections: d4 expiration date, g3, g6, h4, h6 component code, device code(s), type of investigation, investigation findings, and investigation conclusions.The device history record 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.Complaint is confirmed.An edwards manufacturing defect is confirmed.A capa was initiated and investigated and identified two root causes for the defect: human error and lack of sufficient details in documentation.Corrective actions have been taken to address the aforementioned root causes.
Additional Manufacturer Narrative
H10.Corrected data: based on the additional information obtained, this event is no longer considered reportable and this correction is being submitted.

• Brand Name: CARPENTIER-EDWARDS PHYSIO II ANNULOPLASTY RING
• Common Device Name: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; 1 edwards way; irvine, CA 92614 ; 9492506615
• MDR Report Key: 16364903
• Report Number: 2015691-2023-10771
• Device Sequence Number: 12605140
• Product Code: KRH
• UDI-Device Identifier: 00690103180206
• UDI-Public: (01)00690103180206(17)270829
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083470
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 5200M30
• Device Catalogue Number: 5200M30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2023
• Supplement Date Received by Manufacturer: 03/01/2023; 04/18/2023; 07/25/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 03/28/2023; 04/28/2023; 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown