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

Model Number 6200T

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Endocarditis (1834); Tricuspid Regurgitation (2112)

Event Date 04/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Prosthetic endocarditis, with or without vegetation, is a serious complication of cardiac valve repair surgeries.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery.Edwards lifesciences produces and provides sterile tissue bioprostheses to its customers by following carefully designed robust sterilization processes.Validated testing has demonstrated that microorganisms could not survive edwards' multi-stage processing with enhanced sterilant or heated glutaraldehyde terminal sterilant solution.These multiple, redundant manufacturing controls ensure the sterility of edwards' devices as provided to customers.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.(b)(4).

Event Description

Edwards received information that this 26mm tricuspid annuloplasty ring was explanted after twenty-five (25) days due to regurgitation, secondary to infective endocarditis and vegetation.As reported, the patient was discharged from the hospital and post-operative condition was well.The patient was emergently transferred back to the hospital due to suspicion of infective endocarditis.On pod #25, regurgitation was detected due to endocarditis.The decision was made to replace the ring and upon visualization, vegetation on all cups of the native valve were detected.The ring was removed and replaced with another 26 mm tricuspid annuloplasty ring.The patient status was reported as "under treatment" at icu.

Manufacturer Narrative

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 PHYSIO TRICUSPID ANNULOPLASTY RING
• Type of Device: ANNULOPLASTY RING
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: trushala nerurkar ; 1 edwards way; ms: lfs-33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6525804
• MDR Text Key: 73825229
• Report Number: 2015691-2017-01133
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103520
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/04/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2021
• Device Model Number: 6200T
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2017
• Initial Date FDA Received: 04/27/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 62 YR
• Patient Weight: 36