MAUDE Adverse Event Report: EDWARDS LIFESCIENCES STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS; HEART-VALVE, MECHANICAL

Model Number 6120

Device Problems Gradient Increase (1270); Patient Device Interaction Problem (4001)

Patient Problems Atrial Flutter (1730); Dyspnea (1816); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/01/2021

Event Type  Injury  

Manufacturer Narrative

The date of event is unknown; however, the date when the article was received for publication (1 nov 2021) was used as the occurrence date.The device was not returned for evaluation, as the device request is ongoing.Article citation: rahmouni k, naidu j, pearce n, chan v.Successful explantation of a ball and cage mitral valve prosthesis 48 years after initial implantation.Cjc open.2021 nov 21;4(3):344-346.Doi: 10.1016/j.Cjco.2021.11.007.Pmid: 35386136; pmcid: pmc8978051.The investigation is still in progress; therefore, a conclusion has yet to be established.A supplemental report will be submitted accordingly upon investigation completion.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

Through review of medical article " successful explantation of a ball and cage mitral valve prosthesis 48 years after initial implantation" , the following event was identified as pertaining to an edwards device: this 58-year-old patient underwent explantation of a starr-edwards ball and cage prosthesis from the mitral position after an implant duration of forty-eight (48) years.Patient developed nyha class iv dyspnea refractory to medical therapy and experienced chronic atrial flutter.Transthoracic echocardiography (tee) confirmed severe mitral stenosis with a mean gradient of 17 mm hg and a peak gradient of 35 mm hg.Intraoperatively, the prosthesis was covered in dense calcified pannus.A non-edwards mechanical valve was implanted in replacement.Patient remained well, without functional limitations, ten (10) months after the surgery.

Manufacturer Narrative

The serial number was not provided.Therefore, the device history record (dhr) could not be reviewed.The growth of host tissue on the sewing ring is expected and is a natural part of the healing reaction to prosthesis implantation.A small amount of host tissue growth over the suture line is needed to form a non-thrombogenic surface and complete the healing process after valve implantation.In contrast, if there is an excessive amount of pannus growth, it can lead to restricted mobility, elevated gradients, and stenosis.Host fibrous (pannus) tissue growth is not a malfunction of the device.The most likely cause is patient factors.

• Brand Name: STARR-EDWARDS SILASTIC BALL HEART VALVE PROSTHESIS
• Type of Device: HEART-VALVE, MECHANICAL
• 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: 16625822
• MDR Text Key: 312102719
• Report Number: 2015691-2023-11914
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P870038
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female