MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION DURAN ANCORE RING; RING, ANNULOPLASTY

Model Number 620R

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Unspecified Infection (1930); Pleural Effusion (2010); Renal Failure (2041); Regurgitation, Valvular (2335); Low Cardiac Output (2501); Blood Loss (2597)

Event Date 10/23/2019

Event Type  Injury  

Manufacturer Narrative

Citation: salihi s et al.Durability of mitral valve repair: a single center experience.Turk gogus kalp damar cerrahisi derg.2019 oct 23;27(4):459-468.Doi: 10.5606/tgkdc.Dergisi.2019.18165.Ecollection 2019 oct.Earliest date of publish used for event date.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 clinical outcomes of surgical mitral valve repair in patients with different etiologies.All data were retrospectively collected from a single center between june 2006 and august 2017.The study population included 421 patients (predominantly male, mean age 53.1 years).Devices from multiple manufacturers were implanted in the study population.An unspecified of patients received a medtronic duran ancore annuloplasty rings (no serial numbers provided).Among all patients, 5 early in-hospital deaths (4 cardiac, 1 non-cardiac) and 14 late deaths (6 cardiac, 8 non-cardiac) occurred.For the in-hospital deaths, 4 were due to low cardiac output and 1 was due to acute renal failure.For the late deaths, 2 were due to congestive heart failure, 2 due to sudden death, 1 due to acute aortic dissection, and 1 due to myocardial infarction.No further details were provided on these deaths.Based on the available information medtronic product was not directly associated with the death(s).Among all patients adverse events included: low cardiac output syndrome, extracorporeal membrane oxygenation (ecmo) support, intra-aortic balloon pump support, new-onset atrial fibrillation, pleural effusion requiring drainage, bleeding requiring reoperation, post-operative renal failure, stroke, surgical wound infection, permanent pacemaker implantation, pulmonary complications, prolonged mechanical ventilation, moderate to severe mitral regurgitation recurrence, and endocarditis.Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: DURAN ANCORE 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10171249
• MDR Text Key: 199640236
• Report Number: 2025587-2020-01960
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K960356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 620R
• Device Catalogue Number: 620R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/26/2020
• 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: 53 YR