MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY

Model Number 800SR34

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Calcium Deposits/Calcification (1758); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 1 year and 7 months post implant of this 34mm mitral annuloplasty ring, it was reported that an echocardiogram (echo) performed noted moderate to severe mitral valve regurgitation.It was stated that the patient is displaying the same symptoms as seen prior to the mitral valve repair.It was also reported that the patient has a scheduled future diagnostic assessment for a transesophageal echocardiogram (tee) and 4d-computed tomography scan (4d-ct) to determine if a reintervention is needed. it was reported that 1 month later, a transesophageal echocardiogram was performed which noted severe mitral valve regurgitation.Subsequently 2 months later, a ct scan discovered pronounced calcification of the patient's mitral valve annulus and the patient's native mitral valve leaflets appeared thickened.It was also reported that 3 days later, the annuloplasty ring was explanted and replaced with a non-medtronic product.It was reported that the event was not related to the 34mm mitral annuloplasty ring.No additional adverse patient effects were reported.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY RING
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16461313
• MDR Text Key: 310444531
• Report Number: 2025587-2023-00749
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169182264
• UDI-Public: 00643169182264
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072655
• 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
• Report Date: 03/01/2023

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: 800SR34
• Device Catalogue Number: 800SR34
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/16/2023
• Initial Date FDA Received: 03/01/2023
• 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
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 52 KG