MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONTOUR 3D ANNULOPLASTY RING; RING, ANNULOPLASTY

Model Number 690R

Device Problem Incomplete Coaptation (2507)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Heart Block (4444); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 10/29/2021

Event Type  Injury  

Manufacturer Narrative

Citation: dzilic et al.Results after repair of functional tricuspid regurgitation with a three-dimensional annuloplasty ring.J clin med.2021 oct 29;10(21):5080.Doi: 10.3390/jcm10215080.Earliest date of publish 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 results after repair of functional tricuspid regurgitation with a three-dimensional annuloplasty ring.All data were retrospectively collected from a single german medical center between december 2010 and january 2017.The study population included 468 patients (predominantly male, mean age 69.4 years).All patients were implanted with a medtronic contour 3d annuloplasty ring (unique device identifier numbers not provided).Among all patients there were 23 deaths, which included one peri-operative death due to uncontrollable bleeding and 22 deaths within 30 days of implant.Based on the available information medtronic product was not directly associated with the death(s).Among all patients, adverse events included: ischemic stroke, third-degree atrio-ventricular (av) block requiring permanent pacemaker, and reoperation for various cardiac-related issues such as endocarditis and restrictive motion or prolapse of valve leaflet. additionally, severe tricuspid regurgitation was observed at 4 to 6 years post-implant, which the physician/authors stated was comparable with findings of other studies.Based on the available information medtronic product were likely associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: CONTOUR 3D ANNULOPLASTY 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: 13725946
• MDR Text Key: 290289460
• Report Number: 2025587-2022-00654
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K101212
• 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: 03/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 690R
• Device Catalogue Number: 690R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2022
• 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): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Male