MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS MITRIS RESILIA MITRAL VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 11400M

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/12/2023

Event Type  Injury  

Event Description

It was reported that a piece of the retaining blue thread on the holder base of a 25mm 11400m mitral pericardial valve was cut at the wrong two sites by the surgeon.During mitral valve replacement with this device, when unfolding the commissure stent posts, the surgeon cut the retaining blue thread at the wrong two sites on the holder base, not at the single cut point that indicated in the ifu, with a possibility of falling a piece of retaining thread into the cardiac cavity.The retaining blue thread remained attached to the returned holder was not kept in the same condition as at the time of the event, because the surgeon reportedly cut it in some location for some reason after the surgery.No pieces of thread had fallen into the left ventricle or were entangled with the valve.Intraoperative and post bypass echo showed no regurgitation.The patient returned to the icu.The patient status was reported as recovered.There was no allegation of device malfunction.This case was the sixth mitris case for the surgeon.The surgeon had cut the retaining blue thread at the correct cut point as per the ifu in the previous cases, but in this case he cut it at wrong sites, and the reason for this was not provided.The surgeon requested ew to provide information on how many threads the retaining blue thread on the holder base consists of and what shape the retaining blue thread usually remains in the removed holder base when cutting the way he did in this case.The holder was returned for evaluation.Intraoperative photos of the holder and videos of echo are provided.

Manufacturer Narrative

H10: additional narratives: it was reported that the surgeon cut the retaining blue thread at two wrong sites on the holder base to unfold the commissure stent post instead of the single cut point, indicated in the ifu.When the retaining suture is not cut correctly according to the ifu, there is a potential for a piece of thread to fall into the cardiac cavity and embolize.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.

Manufacturer Narrative

H10: additional manufacturer narrative: product evaluation summary: customer report that valve was cut at the wrong two sites by the surgeon was confirmed.Only a valve holder was returned; valve was not returned.The blue sutures of the holder were cut at the cutting channel area and also cut/torn at the outflow aspect side of the holder.Three pieces of the blue holder sutures remained attached.The two long pieces were approximately 6 cm long and had straight and even cut ends.The short piece was approximately 0.5 cm long and the end appeared frayed and torn.Engineering evaluation summary: complaint is confirmed.There is no evidence to suggest an edwards manufacturing defect.Capa/scar is not required.Root cause analysis: there was no allegation of device malfunction.Although there was no allegation of device malfunction, a dhr review was performed, and no relevant non-conformances were identified.Images of the subject holder base and attached holder suture thread were provided for evaluation along with intraoperative photos of the holder and echo imaging.Although a mobile structure suggestive of a retaining thread is not selectively visualized within the lv cavity, a) in any scenario, 2-dimensional imaging with echocardiography could have a low sensitivity for the detection of a very small intracardiac structure, b) only a small portion of the lv is visualized in the submitted movies, and c) owing to acoustic shadowing and reverberation artifact, it likely would not be possible to discriminate the presence of a small piece of thread if it was located within or close to the location of intracardiac air.It was reported by the customer that no pieces of thread had fallen into the left ventricle or were entangled with the valve and the patient status was reported as recovered.The ifu contains figures showing where to cut the threads on the holder base correctly.The surgeon had reportedly cut the retaining blue thread at the correct cut point as per the ifu in the previous cases, but in this case, he cut it at wrong sites and the reason for this was not provided.Based on the information available, the most likely cause of the reported incident is unintentional use error.An edwards defect has not been confirmed.All pertinent information available to edwards lifesciences has been submitted.

Event Description

It was reported that a piece of the retaining blue thread on the holder base of a 25mm 11400m mitral pericardial valve was cut at the wrong two sites by the surgeon.During mitral valve replacement with this device, when unfolding the commissure stent posts, the surgeon cut the retaining blue thread at the wrong two sites on the holder base, not at the single cut point that indicated in the ifu.Since cutting the retaining thread at those two sites was not enough to remove the holder base from the valve, the surgeon further cut the thread between the holder base and the valve, and the holder base was finally removed.This event might have caused a piece of retaining thread to fall into the cardiac cavity.The retaining blue thread remained attached to the returned holder was not kept in the same condition as at the time of the event, because the surgeon reportedly cut the thread at the cut point indicated in the ifu to confirm the correct cut point after the surgery.No pieces of thread had fallen into the left ventricle or were entangled with the valve.Intraoperative and post bypass echo showed no regurgitation.The patient returned to the icu.The patient status was reported as recovered.There was no allegation of device malfunction.This case was the sixth mitris case for the surgeon.The surgeon had cut the retaining blue thread at the correct cut point as per the ifu in the previous cases, but in this case he cut it at wrong sites, and the reason for this was not provided.

• Brand Name: EDWARDS MITRIS RESILIA MITRAL VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• Manufacturer Contact: saurav singh ; one edwards way; mle fl2- office m2013; irvine, CA 92614 ; 9492506615
• MDR Report Key: 17076554
• MDR Text Key: 316662200
• Report Number: 2015691-2023-13479
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150048
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2023
• 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; Hospitalization; Life Threatening