MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-FLEX TRICUSPID ANNU RING; RING, ANNULOPLASTY

Model Number 900FC

Device Problem Material Separation (1562)

Patient Problems Atrial Fibrillation (1729); Endocarditis (1834); Mitral Valve Insufficiency/ Regurgitation (4451); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/19/2022

Event Type  Injury  

Manufacturer Narrative

Citation: sideris et al.Repair of mitral valves with severe annular dilatation and abundant leaflet tissue using a prosthetic ring with a large anterior-posterior diameter.J clin med.2022 mar 19;11(6):1709.Doi: 10.3390/jcm11061709.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding repair of mitral valves using a prosthetic ring with a large anterior-posterior diameter.All data were collected from a single german center between november 2015 and december 2019.The study population included 378 patients who were predominantly male with a mean age of 58 years.All patients were implanted with a medtronic simulus annuloplasty ring.No unique device identifier numbers were provided.Among all patients, there was one death within 30 days and seven deaths during the follow-up period with a mean of 2.4 years.No further details were provided on the deaths.There was no statement of causal or contributory relationship between medtronic product and the deaths.Among all patients, post-implant adverse events included: moderate to severe mitral regurgitation (mr), atrial fibrillation, ring dehiscence requiring intervention, and endocarditis requiring intervention.Based on the available information medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: SIMULUS SEMI-FLEX TRICUSPID ANNU 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: 14951280
• MDR Text Key: 295473824
• Report Number: 2025587-2022-01864
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052899
• 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
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 900FC
• Device Catalogue Number: 900FC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male