MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CG FUTURE BAND; RING, ANNULOPLASTY

Model Number 638B

Device Problem Backflow (1064)

Patient Problems Pulmonary Embolism (1498); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Mitral Regurgitation (1964); Myocardial Infarction (1969); Sepsis (2067); Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Respiratory Failure (2484); Blood Loss (2597)

Event Date 06/22/2013

Event Type  Injury  

Manufacturer Narrative

Citation: yaffee d., et al.Long-term results of mitral valve repair with semi-rigid posterior band annuloplasty.J heart valve dis.2014 jan;23(1):66-71.Pmid: (b)(6).Presented at the seventh biennial congress of the society for heart valve disease and heart valve society of america, 22nd-25th june 2013, palazzo del casinò, venice, italy 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.(b)(4).

Event Description

Medtronic received information via literature comparing long term outcomes after mitral valve repair using complete annuloplasty rings versus semi-rigid posterior bands.All data were collected from a single center between january 1993 and december 2010.The study population included 1612 patients (predominantly male, mean age 62 years), 1101 of whom were implanted with medtronic cg future band posterior bands (no serial numbers provided).Among all medtronic cg future band patients, 21 in-hospital deaths occurred.Over the course of 8-year follow-up, all-cause mortality was 23%.No further information was provided.Based on the available information, medtronic product was not directly associated with the deaths.Among all medtronic cg future band patients, adverse events included: myocardial infarctions, strokes, transient ischemic attacks (tias), cardiac tamponade, pulmonary embolism, sepsis, respiratory failure, endocarditis, bleeding, need for permanent pacemaker/implantable cardioverter defibrillator (icd) implantation, and need for mitral valve re-operations due to recurrent severe mitral regurgitation.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.

Event Description

Additional information received from the physician/author stated that medtronic product did not cause or contribute to the observed adverse events.

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.

• Brand Name: CG FUTURE BAND
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10172354
• MDR Text Key: 195887234
• Report Number: 2025587-2020-01965
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K052860
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 06/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 638B
• Device Catalogue Number: 638B
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/19/2020
• Supplement Dates Manufacturer Received: 06/25/2020
• Supplement Dates FDA Received: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 62 YR