MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS; REPLACEMENT HEART-VALVE

Model Number	6900P
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional manufacturer narrative: bioprosthetic tissue valves can deteriorate with time and eventually fail contributing to regurgitation and/or stenosis.Structural valve deterioration (svd) is the most common reason for bioprosthesis explants and encompasses multiple failure modes, including calcification, non-calcific degeneration, dehiscence, cusp thickening or fibrosis, or a combination of these.Such failure modes may occur singularly or concomitantly.Alternatively, nonstructural dysfunction (nsvd) may also play a role in the development of valvular regurgitation and/or stenosis.Multiple requests for additional details regarding this event have been performed.At this time, there is currently insufficient information to determine the root cause of this event.The subject device was not returned evaluation; therefore, the complaint cannot be confirmed.The device history record (dhr) review was completed, and this device passed all manufacturing and sterilization inspections prior to release for distribution.There were no issues identified that would have impacted this event.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.If any additional information is received, a supplemental report will be submitted accordingly.
Event or Problem Description
It was reported that 27mm 6900p mitral valve was explanted after an unknown implant duration due to unknown reason.The explanted valve was replaced with a st.Jude epic mitral valve.No other details have been provided.
Additional Manufacturer Narrative
H11: corrected data: corrected h6 component codes by replacing code-527 with code-4755.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT PLUS PERICARDIAL BIOPROSTHESIS
• Common Device Name: REPLACEMENT HEART-VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11757785
• Report Number: 2015691-2021-02757
• Device Sequence Number: 11804296
• Product Code: DYE
• UDI-Device Identifier: 00690103152647
• UDI-Public: 00690103152647
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P860057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/15/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/25/2015
• Device Model Number: 6900P
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 06/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR