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

Model Number 4450

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Adhesion(s) (1695); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Mitral Valve Stenosis (1965); Tricuspid Insufficiency (2111)

Event Date 08/07/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Host fibrous (pannus) tissue growth is expected in all prosthetic/bioprosthetic heart valves/annuloplasty rings and is largely attributable to the host response (such as the foreign body reaction) to the implants.In vast majority cases, the pannus tissue is from surrounding native anatomy such as annulus.The time course and severity of pannus growth is largely variable among the patients.The underlying mechanism is still not fully understood, but it is generally believed that the patient factors (such as patient immune system, age, other comorbidities, local anatomy et.Al.) may play important roles in pannus growth.The explanted ring has not been returned for evaluation; the reported event was not confirmed.The root cause of this event cannot be conclusively determined; however, it is likely that patient related factors contributed to this event.

Event Description

Edwards lifesciences maintains an implant patient registry.This registry is a patient tracking mechanism for serialized edwards implantable devices (bioprosthetic heart valves and annuloplasty rings), rather than a true post-market surveillance registry.Through the registry, edwards is notified when these devices are implanted.In addition, patient and/or device status may be reported to the registry via the implantation data cards.The information is received from various sources (e.G.Surgeon, hospital and patient family members) and is not received in the form of a conventional "customer complaint." the information reported may or may not be related to the edwards device.In this case, it was learned that a model 4450 30mm mitral ring, implanted approximately for three (3) years and eight (8) months, was explanted due to significant pannus tissue leading to immobilized leaflets and severe stenosis.The explanted device was replaced with a model 5200 34mm ring.Per medical records, this case involved a (b)(6) year-old male with a history of mvr, placement of gore-tex chords, phtn, chronic atrial fibrillation and htn.He presented with significant exertional shortness of breath.He was found to have severe mitral stenosis, significant tricuspid insufficiency, and severe pulmonary hypertension.He underwent mv ring repair with extensive debridement of pannus and a tv ring repair.Intraoperatively, there was very dense adhesions between the heart and surrounding tissues.The ring appeared to be placed onto the leaflets and there was a lot of pannus because of possibly use of pledgeted sutures.The 4450 30mm mitral ring along with previous sutures were removed and it was noted there was a significant amount of pannus holding the leaflets down.The posterior annulus was brought in with good competence so the decision was made to re-do the repair.A 5200 34mm ring was seated and secured in place using cor-knots.Attention was turned to tricuspid annulus.The tricuspid valve was repaired with a mc3 ring, which was seated and sutured in place resulting in good competence.It was noted a larger size ring was implanted due to severe pulmonary hypertension.The patient was weaned from cpb without any difficulty.Echocardiogram showed good ventricular function, well functioning mitral valve with trivial insufficiency, and well functioning tricuspid valve with no significant insufficiency.It was noted that patient tolerated the procedure well and was taken to cvicu in stable condition.

Manufacturer Narrative

The report of pannus was confirmed.Report of "immobilized leaflets and severe stenosis" could not be confirmed through visual observations.Moderate to heavy host tissue was observed on the ring.Fragments of host tissue and pledgets were also returned with the ring.X-ray demonstrated the ring to be intact.The cloth was observed to be cut and torn at multiple locations, and exposed the ring and silicone.Straight and event cuts were observed across some of the cloth bundles.Cuts were also seen on the silicone.

Manufacturer Narrative

The device history record (dhr) was not reviewed as the reported event does not allege a malfunction that could be related to a manufacturing deficiency and/or one was not confirmed through investigation.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: CARPENTIER-EDWARDS PHYSIO ANNULOPLASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 7870862
• MDR Text Key: 120098608
• Report Number: 2015691-2018-03776
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K926138
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/20/2018

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: 08/18/2019
• Device Model Number: 4450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2018
• Initial Date Manufacturer Received: 08/20/2018
• Initial Date FDA Received: 09/12/2018
• Supplement Dates Manufacturer Received: 08/20/2018; 10/04/2018; 07/23/2020
• Supplement Dates FDA Received: 10/02/2018; 10/17/2018; 12/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 65 YR