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

Model Number 620R

Device Problem Unintended Movement (3026)

Patient Problems Host-Tissue Reaction (1297); Atrial Fibrillation (1729); Stroke/CVA (1770); Congestive Heart Failure (1783); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemolysis (1886); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Transient Ischemic Attack (2109); Tricuspid Regurgitation (2112); Blood Loss (2597); Thromboembolism (2654)

Event Date 08/27/2019

Event Type  Injury  

Manufacturer Narrative

Citation: david te et al.Long-term results of mitral valve repair for regurgitation due to leaflet prolapse.Journal of the american college of cardiology.2019; 74(8):1044-1053.Doi: 10.1016/j.Jacc.2019.06.052.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 the long-term results of mitral valve repair for correcting regurgitation following leaflet prolapse.All data were collected from multiple centers between 1981 and 2010.The study population included 1234 patients (predominantly male, median age 59 years), 152 of which were implanted with medtronic duran annuloplasty rings (no serial numbers provided).Among all patients, 324 deaths occurred throughout the follow-up period.It was reported that 7 deaths occurred within 90 days of implant, and 317 deaths occurred beyond 90 days post implant.Of the late-stage deaths, 115 were classified as cardiac, 193 non-cardiac, and 9 unknown cause.Furthermore, 2 deaths occurred during reoperation, 2 deaths occurred from endocarditis, 14 deaths occurred following a stroke, 11 deaths occurred from major bleeding, and 1 death occurred from heart failure.Multiple manufacturers were noted in the literature, and there was no association between medtronic product and any of the deaths.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: infective endocarditis, thromboembolism, stroke, transient ischemic attack (tia), major bleeding, hemolysis, systolic anterior motion, stenosis, pannus formation, heart failure, moderate-severe mitral regurgitation, mod erate-severe tricuspid regurgitation, pacemaker implantation, atrial fibrillation.A total of 48 patients required reoperation.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: 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: 10041617
• MDR Text Key: 196938997
• Report Number: 2025587-2020-01601
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K032810
• 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: 05/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2020
• 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: 05/06/2020
• 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): Required Intervention
• Patient Age: 59 YR