MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING TRI-AD 900SFC26; RING, ANNULOPLASTY

Model Number 900SFC26

Device Problem Backflow (1064)

Patient Problems Tricuspid Regurgitation (2112); Complete Heart Block (2627)

Event Date 08/31/2019

Event Type  Injury  

Manufacturer Narrative

Citation: brescia a., et al.Outcomes of guideline-directed concomitant annuloplasty for functional tricuspid regurgitation.Ann thorac surg.2020 apr;109(4):1227-1232.Doi: 10.1016/j.Athoracsur.2019.07.035.Epub 2019 aug 31.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 morbidity/mortality after concomitant tricuspid valve surgical repair performed with mitral/aortic valve surgical repair or replacement and surgical atrial fibrillation ablation.All data were collected from a single center between may 2012 and march 2016.The study population included 171 patients (predominantly male, predominantly caucasian, mean age 68 years), all of whom were implanted with medtronic tri-ad annuloplasty rings (no serial numbers provided).Among all medtronic tri-ad patients, 1 death occurred within 30 days post-procedure.The survival rate was 95% at 1 year and 92% at 5 years.No further information was provided.Based on the available information medtronic product was not directly associated with the deaths.Among all medtronic tri-ad patients, adverse events included: pacemaker implantation for post-operative complete heart block, unspecified need for hospital re-admissions and post-operative mild-moderate-severe tricuspid regurgitation.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 not cause or contribute to the observed deaths or adverse events.

• Brand Name: RING TRI-AD 900SFC26
• Type of Device: RING, ANNULOPLASTY
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10048640
• MDR Text Key: 196980861
• Report Number: 2025587-2020-01610
• Device Sequence Number: 1
• Product Code: KRH
• Combination Product (y/n): N
• PMA/PMN Number: K093903
• 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: 08/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 900SFC26
• Device Catalogue Number: 900SFC26
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR