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

Model Number 2800TFX

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583)

Patient Problem Insufficient Information (4580)

Event Date 11/26/2020

Event Type  Injury  

Manufacturer Narrative

The device was not returned to edwards for evaluation.The device history record (dhr) was unable to be reviewed as the device serial number was not provided.Regurgitation is considered to be a perivalvular leak (pvl) if a turbulent eccentric jet originates between the bioprosthetic sewing ring and the annulus.A definitive root cause could not be determined.If additional information is received a supplemental mdr will be submitted.Edwards lifesciences will continue to monitor all reported events.No further actions are required at this time.

Event Description

Edwards received notification that this 23mm valve was explanted from the aortic position due to sizing issues leading to paravalvular leak (pvl).A 21mm valve\ was implanted in replacement.The patient was in stable condition after the procedure.

Event Description

Edwards received notification that this 23mm valve was explanted at implant from the aortic position due to sizing issues leading to paravalvular leak (pvl).The pvl was observed visually during the intervention.As reported, the 23mm valve sizer was very loose and fitted initially in the patient's annulus.Reportedly, no anatomical factors were found which could have caused sizing issues during the operation.A 21mm valve was implanted in replacement.The patient did not suffer any injury or adverse event and was in stable condition after the procedure.

Manufacturer Narrative

H10.Additional manufacturer narrative: based on the additional information obtained, this event is no longer considered reportable.H11.Corrected data: 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.

• Brand Name: CARPENTIER-EDWARDS PERIMOUNT THEON PERICARDIAL BIOPROSTHESIS
• Type of Device: REPLACEMENT HEART VALVE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 11049794
• MDR Text Key: 223458806
• Report Number: 2015691-2020-15158
• Device Sequence Number: 1
• Product Code: DYE
• Combination Product (y/n): N
• PMA/PMN Number: P860057/S022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 11/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: 2800TFX
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention