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

Model Number 5200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Endocarditis (1834); Mitral Regurgitation (1964); No Code Available (3191)

Event Date 01/04/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Additional manufacturer narrative: prosthetic endocarditis, with or without vegetation, is a serious complication of cardiac valve replacement and valve repair surgeries.In early cases of prosthetic endocarditis, subsequent infections are almost universally related to contamination at the time of surgery and are unrelated to the device.Edwards lifesciences produces and provides sterile devices to its customers by following carefully designed robust sterilization processes.These manufacturing processes have been validated and demonstrated to consistently provide a significant safety factor from which microorganisms could not survive.Process monitoring is routinely reviewed within quality systems to maintain sterility control.In this case, the explanted device was not returned to edwards for analysis.At this time, edwards lifesciences is unable to conclusively determine the root cause for this event, or confirm the clinical observation.No information was provided to edwards that indicated this device caused or contributed to the events that led to the patient's expiration.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital, and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.In this case, edwards received information that a 36mm annuloplasty ring was explanted after one (1) month due to severe mitral regurgitation, secondary to endocarditis with coagulase-negative staph bacteremia.Tte revealed thickened native mitral valve leaflets, concerning for endocarditis, and tee confirmed mitral valve vegetation.Upon visualization, there was no evidence of abscess or fistula between the mitral and aortic tissue, despite concern on preoperative echo.The native mitral valve tissues demonstrated multiple areas of perforation with very thin, friable tissue.There were no gross vegetations noted.The annuloplasty ring was replaced with a 33mm mitral pericardial bioprosthesis.Moderate tricuspid regurgitation was observed; however, due to the patient's illness, the decision was made to not intervene on the tricuspid valve.A temporary pacemaker was implanted before the patient was weaned from bypass, due to a history of heart block.During the post-operative period, the patient's hemodynamics did not improve despite multiple efforts and maximum support.The decision was made for the patient to be dnr as he remained in multi-system organ failure.On pod #9, the patient became increasingly hypotensive and expired.

Manufacturer Narrative

The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.Udi # (b)(4).

• Brand Name: CARPENTIER-EDWARDS PHYSIO II 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: neil landry ; 1 edwards way; ms: t&d 2nd floor, office t223; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6368004
• MDR Text Key: 68747485
• Report Number: 2015691-2017-00523
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/06/2017

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: 02/02/2021
• Device Model Number: 5200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/06/2017
• Initial Date FDA Received: 03/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2016
• 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
• Treatment: ACETAMINOPHEN; ALLOPURINOL; AMIODARONE; ASPIRIN; ATORVASTATIN; DOCUSATE; FERROUS SULFATE; MAGNESIUM HYDROXIDE; OXYCODONE; POLYETHYLENE GLYCOL; SENNA; TAMSULOSIN; WARFARIN
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 100