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

Model Number 620R

Device Problem Backflow (1064)

Patient Problems Mitral Regurgitation (1964); Respiratory Failure (2484)

Event Date 04/07/2016

Event Type  Injury  

Manufacturer Narrative

Citation: yun-dan d., et al.Comparison of outcomes following mitral valve repair versus replacement for chronic ischemic mitral regurgitation: a meta-analysis.Thorac cardiovasc surg.2017 sep;65(6):432-441.Doi: 10.1055/s-0036-1580603.Pmid: 27056301.Epub 2016 apr 7 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 safety and effectiveness of mitral valve repair versus replacement for ischemic mitral regurgitation.All data were collected from a meta-analysis review of 10 retrospective studies published between 1986 and 2011.The study population included 2,324 patients (predominantly male, mean age 67 years), 98 of whom were implanted with medtronic duran ancore annuloplasty rings and 98 of whom were implanted with medtronic cg future band annuloplasty bands (no serial numbers provided).Among all patients, 30-day and 5-year post-operative mortality were noted, but numbers of deaths were not given and no further information was provided.Based on the available information medtronic product was not directly associated with the deaths.Among all patients, adverse events included: need for re-operation, recurrence of moderate-severe mitral regurgitation and acute respiratory failure.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: 10177609
• MDR Text Key: 198167472
• Report Number: 2025587-2020-01973
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 620R
• Device Catalogue Number: 620R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2020
• 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): Life Threatening; Required Intervention
• Patient Age: 67 YR