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 Host-Tissue Reaction (1297); Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Fistula (1862); Hemolysis (1886); Hemorrhage/Bleeding (1888); Mitral Regurgitation (1964); Mitral Valve Stenosis (1965); Transient Ischemic Attack (2109)

Event Date 10/13/2005

Event Type  Injury  

Manufacturer Narrative

Citation: david t et al.A comparison of outcomes of mitral valve repair for degenerative disease with posterior, anterior, and bileaflet prolapse.J thorac cardiovasc surg.2005 nov;130(5):1242-9.Doi: 10.1016/j.Jtcvs.2005.06.046.Epub 2005 oct 13.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 a comparison of outcomes of mitral valve repair for degenerative disease with posterior, anterior, and bileaflet prolapse.All data were collected from a single center between july 1981 and june 2001.The study population included 701 patients (predominantly male, overall mean age 56.7 years), 166 of whom were implanted with medtronic duran ring (no serial numbers provided) for mitral valve surgical repair.Among all patients there were 5 operative and 98 late deaths (18 valve-related, 32 cardiac, and 48 non-cardiac deaths).The authors discussed predictors of these deaths, but no further details were provided regarding the causes of death.Based on the available in formation medtronic product may have been associated with the death(s).Among all patients, adverse events included: stroke, transient ischemic attack (tia), major hemorrhage during anticoagulation therapy, infective endocarditis, severe mitral regurgitation (mr), and atrial fibrillation.Additionally the following adverse events required reoperation: severe mr, hemolysis caused by residual mr, mitral stenosis caused by pannus, infective endocarditis, and left ventricular-coronary sinus fistula.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.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the physician/author stated that medtronic product did relate directly to five adverse event requiring reoperation, however those adverse events were not specified.No further details were provided.

• 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
• MDR Report Key: 10433923
• MDR Text Key: 203905766
• Report Number: 2025587-2020-02642
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K960356
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• 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
• Date Manufacturer Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 57 YR