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 No Information (3190)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Evaluation summary: the annuloplasty ring holder was returned to edwards for analysis.As received, one (1) side of the clip of the holder was found broken off.The broken clip piece was returned with the rest of the ring holder.Edges of the broken piece matched up with rest of the holder.The annuloplasty ring was not returned with the holder and no other inconsistencies were detected.(b)(4).The clinical report of a broken ring holder could be confirmed through visual observations.Holders that fragment when in use within the operative field have the potential to result in a piece being retained in the heart that could then embolize when the patient¿s heart begins beating.This malfunction has the potential to cause a stroke or myocardial infarction.In this case, although a broken piece was found lying in the operative field, the piece was removed by the assisting surgeon and the corresponding broken piece matched up to the holder upon return to edwards lifesciences.The annuloplasty ring was not returned to edwards as it remains implanted in the patient with no reported complications.The device history record (dhr) review was completed and this device passed all manufacturing and sterilization inspections.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 received information that the holder for this annuloplasty ring broke during a procedure.As reported, the operating room staff was attaching the handle to the holder with a lot of force.At this time, the portion of the holder which attaches to the handle broke.The edwards representative noticed a broken piece lying in the operative field and the assisting surgeon retrieved it.The annuloplasty ring remains implanted and there were no further complications; the patient was noted as doing well, post-operatively.

• 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: 5810037
• MDR Text Key: 50066926
• Report Number: 2015691-2016-02284
• 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,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/23/2021
• Device Model Number: 5200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/21/2016
• Initial Date FDA Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/27/2016
• 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 Age: 63 YR