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

Model Number 5200

Device Problem Use of Device Problem (1670)

Patient Problems Arrhythmia (1721); Myocardial Infarction (1969); Thrombosis (2100)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

Through investigation it was determined that this event was due to a use error.There was no allegation of device malfunction; however, this type of use error did cause or would likely cause or contribute to a serious injury or death.In this case, the patient experienced a post-operative myocardial infarction due to ring-suture thrombosis of the left circumflex artery during the implant of the suture ring.The device was not returned for evaluation, as it remains implanted.The root cause of this event cannot be conclusively determined.However, it is likely that patient related and/or procedural factors contributed to the event.The device history record (dhr) was reviewed and showed that this device met all manufacturing and sterilization specifications for product release prior to distribution.No issues were identified that would have impacted this event.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

It was learned via a customer report, and subsequent medical records that a patient with a 28mm mitral ring developed post-operative myocardial infarction because of ring-suture loop and lcx thrombosis, due to unintentional use error.Per medical records, patient presented with severe mr + tr and underwent mv repair+primary closure of septal perforation from healed endocarditis +tv repair + cox-maze iv biatrial maze.Upon inspecting the mitral valve, there was evidence of perforation in p2 with 2 small jets that were emanating from that.They were closed with 5-0 prolene.The team then placed annuloplasty suture rings and sized the patient for a 28 mm ring, which was secured with cor-knots with evidence of no regurgitation.The patient was weaned from bypass without difficulty.Both mitral and tricuspid valves were competent without any regurgitation or sam.The post-op course was complicated by persistent sinus node dysfunction, anemia, hyponatremia, and posterior myocardial infarction.On pod #5 the patient required a ppm placement.Patient was discharged on pod #13 in good condition.

Manufacturer Narrative

Corrected data: f10, h6.Reference (b)(4).

Manufacturer Narrative

Updated h6 per new information received.Udi number (01) (b)(4),(17) (b)(4),(21) (b)(4).

• Brand Name: CARPENTIER-EDWARDS PHYSIO II RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 10114748
• MDR Text Key: 193927434
• Report Number: 2015691-2020-12043
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K083470
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2020

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: 09/17/2023
• Device Model Number: 5200
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/11/2020
• Initial Date FDA Received: 06/03/2020
• Supplement Dates Manufacturer Received: 07/23/2020; 07/23/2020
• Supplement Dates FDA Received: 07/24/2020; 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR