MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM; RING, ANNULOPLASTY

Model Number 4900

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Atrial Fibrillation (1729); Occlusion (1984); Complete Heart Block (2627)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

The literature states that: in this presented case of iatrogenic rca injury during mitral and tricuspid valve repair, a new isolated inferior basal wall motion abnormality was identified on tee soon after release of the aortic cross-clamp.While all new signs suggestive of myocardial ischemia following cardiac surgery should be investigated thoroughly, the appearance of new inferior basal wall hypokinesia presents a dilemma for the cardiac surgical care team, particularly after mitral and tricuspid valve surgery.The difficulty relates to several factors: first, ventricular pacing is frequently required following mitral and tricuspid valve surgery; secondly, during transgastric tee imaging, the severity of any inferior wall motion defect may be overestimated, limiting its specificity for ischemia detection; and lastly, the constellation of findings observed during this case are not uncommon following cardiac surgery and may present in many patients who suffer from only self-limited inferior wall motion abnormalities.Arrhythmias and conduction disturbances are common after surgical repair or replacement of the tricuspid and mitral valves due to the proximity of the conduction pathways.Ultimately, the patient recovered despite a prolonged hospitalization, mostly related to the management of atrial fibrillation and need for a pacemaker.A device history record (dhr) review could not be performed, as the serial # of the device was not provided.However, there is no information suggesting that there was a malfunction or deficiency of the edwards annuloplasty ring.If any new information is learned, a supplemental report will be submitted.No corrective action is applicable to this case.Edwards will continue to review and monitor all reported events.Trends are monitored on a monthly basis and if action is required, appropriate investigation will be performed.

Event Description

Edwards was informed of event through literature review of: "right coronary artery occlusion after tricuspid valve ring annuloplasty." author: j.Goldhammer, md, et al.Published on journal of cardiothoracic and vascular anesthesia, vol 29, no 6 (december), 2015: pp 1606-1609.An (b)(6) male with congestive heart failure was referred for surgical management of known severe mitral regurgitation (mr).Preoperative transesophageal echocardiography(tee) revealed severe left atrial enlargement, severe eccentric mr secondary to a flail p2-p3 scallop with annular dilation, left ventricular ejection fraction of 45%, tricuspid annular dilation with moderate central tricuspid regurgitation, and mild right ventricular dilation with preserved systolic function.Preoperative cardiac catheterization prior to surgery had identified diffuse non-critical coronary artery disease in a right dominant circulation and a 60% proximal right coronary artery stenosis.During preoperative surgical consultation, the patient expressed his desire to avoid median sternotomy, and a minimally invasive mitral and tricuspid valve repair was planned.A 30 mm carpentier edwards tricuspid annuloplasty band was selected the tricuspid valve repair.Prior to separation from cpb, tee imaging was notable for moderate left ventricular dysfunction, mild right ventricular dysfunction, trace residual mr, and no tricuspid regurgitation.Post-operatively, diagnostic images revealed a 100% occlusion of the distal right coronary artery directly abutting the tricuspid ring annuloplasty.Multiple attempts to pass a wire through the occlusion site proved unsuccessful, raising suspicion for a mechanical occlusion of the distal right coronary artery (rca).It was decided to transfer the patient back to the intensive care unit for conservative management of the distal rca occlusion and continued postoperative care.The postoperative course was complicated by continued third-degree heart block, ultimately requiring placement of a dual-chamber pacemaker and an episode of severe chest pain and atrial fibrillation on pod #8.Repeat coronary angiography performed following the onset of chest pain revealed stable coronary artery disease with persistent total occlusion of the distal rca.The patient was discharged on pod #15 to a short-term rehab facility.

• Brand Name: EDWARDS MC3 TRICUSPID ANNULOPLASTY SYSTEM
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: neil landry ; 1 edwards way; ms: lfs 33; irvine, CA 92614 ; 9492502289
• MDR Report Key: 6008289
• MDR Text Key: 56791680
• Report Number: 2015691-2016-02966
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2016

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 Model Number: 4900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2016
• Initial Date FDA Received: 10/06/2016
• 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: DUAL-CHAMBER PACEMAKER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 82 YR