MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS; RING, ANNULOPLASTY

Model Number MDT-ANNULOPLASTY

Device Problem Material Separation (1562)

Patient Problems Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Embolism/Embolus (4438); Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

Citation: kaneyuki d, et al.The change in the mitral-septal angle after surgery for atrial functional mitral regurgitation.Gen thorac cardiovasc surg.2021 jan;69(1):1-7.Doi: 10.1007/s11748-020-01408-0.Epub 2020 jun 19.Earliest date of publish used for date of event.Medtronic products referenced: cg future annuloplasty band (pma# k052860, product code krh), profile 3d annuloplasty ring (pma# k073324, product code krh).Earliest approved product used for product code and pma#.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 from a literature article regarding the change in the mitral-septal angle after surgery for atrial functional mitral regurgitation and its effect on mid-term patient outcomes.All data was prospectively collected and retrospectively analyzed from a single center between january 2011 and december 2018.Of the 40 patients included in the study population (predominantly male, mean age 69 years), 3 patients underwent mitral valve annuloplasty with a medtronic cg future band (1) or profile 3d ring (2).No unique device identifier numbers were provided.Among all patients, a total of 7 deaths occurred during follow-up.The causes of death included: congestive heart failure (4) and pneumonia (3).No correlation was made between medtronic product and the deaths.Among all patients, post-operative adverse events included: recurrent moderate or severe mitral regurgitation due toprosthetic ring detachment or posterior mitral leaflet tethering; stroke caused by endocarditis that resulted in heart failure; systemic embolism; permanent pacemaker implantation for sick sinus syndrome; and hospital re-admission for worsening heart failure.Medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC SURGICAL ANNULOPLASTY PRODUCTS
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12215076
• MDR Text Key: 263462089
• Report Number: 2025587-2021-02352
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K052860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-ANNULOPLASTY
• Device Catalogue Number: MDT-ANNULOPLASTY
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2021
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR