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

Model Number 5200M30

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Information (3190)

Event Date 04/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was returned to edwards for evaluation and is pending evaluation.Based on the information received the cause of the event remains indeterminable.A supplemental mdr will be submitted the device evaluation is complete.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 doctor noticed a space in the sewing cloth of this 30 mm ring when inserting sutures to the annulus and the ring before sliding down the ring to the annulus.By considering the risk of insufficient sewing, the ring was not slid down to the annulus and replaced with another 30 mm ring while the patient was on bypass.The patient status was reported as ¿recovered¿ at intensive care unit.The ring was returned for evaluation.Multiple cardiac surgery procedure: tricuspid annuloplasty with 30 mm ring at implant.

Manufacturer Narrative

Evaluation summary: the report of "space in the sewing cloth" was confirmed.The sewing cloth appeared intact but loose near one of the transverse colored threads.Two spaces were observed at loose sewing cloth area.The ring was intact per x-ray imaging.No visible sutures holes around sewing ring.The root cause of this issue cannot be determined at this time.Further investigation is still in progress.A supplemental report will be submitted accordingly.

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.

Manufacturer Narrative

It is true that the loops are more elongated than normal, but this is not considered to be a manufacturing defect.In addition, this elongated loop size does not have any negative impact to the function of the ring.Capa and pra are not required.

• 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: 6544368
• MDR Text Key: 74420036
• Report Number: 2015691-2017-01214
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K083470
• 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,Followup,Followup
• Report Date: 04/12/2017

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 Model Number: 5200M30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/22/2017
• Supplement Dates FDA Received: 05/30/2017; 06/19/2017; 07/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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