MAUDE Adverse Event Report: EDWARDS LIFESCIENCES COSGROVE-EDWARDS® ANNULOPLASTY SYSTEM; RING, ANNULOPLASTY

Model Number 460028MM

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Mitral Regurgitation (1964)

Event Date 06/08/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device was not returned to edwards for evaluation.The clinical observation is unable to be confirmed.There was no allegation of device malfunction.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.Ring dehiscence may occur early or late.When it occurs in the early post-operative period, it is typically a result of an inadequate valve repair in combination with friable myocardial tissue.Late dehiscence can occur as a result of successive dilatation of cardiac structures that result from progression of disease or from endocarditis.Based on the information received, the root cause is most likely operational context that contributed to this event.Of note, the patient received a 30mm ring which was up size from a 27mm ring.No further corrective or preventative actions are required at this time.Edwards will continue to review and monitor all events through the use of edwards quality systems.

Event Description

Edwards received information that the subject device a 27mm annuloplasty ring was explanted after an implant duration of one month and 14 days due to annuloplasty ring dehiscence and recurrent mitral regurgitation.Preoperative tte and tee demonstrated a severe mitral regurgitation with no prolapse of the leaflets, a dehiscenced mitral annular band (ring), a moderate aortic stenosis, and a moderate tricuspid regurgitation with borderline annular dilation.Intraoperatively, the p3 of the mitral valve had 3 torn chordae, which were resected and repaired.The previously implanted annuloplasty mitral ring was dehiscenced from p1-p3.Only 4 stitches were intact.The stitches and the band (ring) were explanted.An edwards 30mm annuloplasty ring was implanted and secured with sutures.There was no residual regurgitation on the saline test.While trying to wean the patient from cardiopulmonary bypass, there were inferior and lateral heart wall motion abnormalities, which improved after placement of an intraaortic bypass balloon pump.At the end of the procedure, there was none-to-trivial mr, mild ar, and mild tr.Eventually, the patient was weaned from cardiopulmonary bypass and he was transferred to the icu in satisfactory condition.

Manufacturer Narrative

Customer report of regurgitation and dehiscence could not be confirmed though visual observations.X-ray demonstrated ring intact.As received, multiple sutures were still attached to the ring.As received, the ring exhibited minimal host tissue overgrowth.

• Brand Name: COSGROVE-EDWARDS® ANNULOPLASTY SYSTEM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; one edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms mle2; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6711445
• MDR Text Key: 79964059
• Report Number: 2015691-2017-02040
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

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: 01/31/2021
• Device Model Number: 460028MM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/13/2017
• Supplement Dates Manufacturer Received: 08/01/2017
• Supplement Dates FDA Received: 08/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2016
• 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): Required Intervention
• Patient Age: 60 YR