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

Model Number 5200

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 12/27/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: (b)(4).The device was not returned to edwards for evaluation.Attempts to retrieve the device were unsuccessful.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.Systolic anterior motion of the mitral valve may occur after mitral valve annuloplasty.It is typically due to redundant native leaflet tissue and may result in left ventricular outflow obstruction after mitral valve repair.This may require additional leaflet resection or a mitral valve replacement.In this case the surgical technique may have contributed to the event due to mis-sizing.The 30mm ring was replaced with a 36mm ring.Edwards will continue to review and monitor all events.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 learned a 30mm mitral ring was explanted after 13 days due to systolic anterior motion (sam) with regurgitation.Per obtained information, the patient was slow to recover after implantation of the 30mm annuloplasty ring and post-operative tte demonstrated sam with mild-to-moderate mitral regurgitation (mr), after initial intra-operatively tte showed no sam or mr.The decision was made to re-repair the mitral valve with a 36mm ring.The prior ring was removed, a sliding plasty of the posterior leaflet was performed, and a 36mm 5200 was used in replacement.The valve was tested and was found to be competent.There were no reported complications and the patient was transferred to the cardiac intensive care unit in critical but stable condition.

• 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: trushala nerurkar ; 1 edwards way; ms lfs 33; irvine, CA 92614 ; 9492501377
• MDR Report Key: 6321803
• MDR Text Key: 67108027
• Report Number: 2015691-2017-00325
• 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
• Report Date: 01/18/2017

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: 10/03/2021
• Device Model Number: 5200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2017
• Initial Date FDA Received: 02/10/2017
• Date Device Manufactured: 10/14/2016
• 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: LASIX,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 91