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

Model Number 4450M34

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 09/05/2023

Event Type  Injury  

Manufacturer Narrative

H10: 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 Description

It was learned via the patient registry that a patient with a 34mm 4450m annuloplasty ring in the mitral position underwent a mitral valve replacement procedure after an implant duration of six (6) years, 10 months and 26 days due to unknown reasons.Idc card indicates deficiency of device the annuloplasty ring and native mitral valve were explanted and replaced with a 29mm 11400m mitris valve.The patient was noted to be in recovery post procedure.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections prior to release for distribution.An engineering evaluation is not required because there is no allegation of a malfunction which could be related to a manufacturing non-conformance; no labeling non-conformance/deficiency; no use-related issue with a hazardous situation; no device-related infection; and there is no evidence of a product failure with regard to design, reliability, or use error.Ifu review unable to be performed as no details regarding a failure mode of the device were provided.No details regarding what issue caused the device to be explanted.For products not returned, an engineering evaluation may be triggered if there is an allegation of a device malfunction that could be related to a manufacturing non-conformance.Although the product was not returned and there is an allegation that the event was due to a deficiency in the original device, there is no information available to suggest the allegation is related to a manufacturing non-conformance or a product failure (with regard to design, reliability, or use error) with a moderate, major, or critical severity.Thus, a full engineering evaluation will not be performed.A capa/scar/pra is not required as there are no confirmed product or labeling nonconformances and no other triggers are met.Based on the information available, a definitive root cause cannot be conclusively determined.

• Brand Name: CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
• Type of Device: 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: 17961441
• MDR Text Key: 326005199
• Report Number: 2015691-2023-16897
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K926138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/29/2020
• Device Model Number: 4450M34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/19/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 12/01/2023
• Supplement Dates FDA Received: 12/11/2023
• Date Device Manufactured: 03/30/2016
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Female