MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG33 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number 620BG33

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Fever (1858); Nausea (1970); Prolapse (2475); Pericardial Effusion (3271); Heart Block (4444); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)

Event Date 01/24/2023

Event Type  Injury  

Event Description

Medtronic received information that after an unknown duration post implant of this 33mm mitral annuloplasty band, it was explanted and replaced with a 42mm band of a different model.The reason for the replacement was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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 was received that the reason for replacement was reported as systolic anterior motion (sam), additionally transesophageal echocardiography (tee) showed mod to severe prolapse of poster leaflet, moderate to severe regurgitation.Post operatively the patient developed type 1, 2* atrioventricular (av block) heart block with no intervention reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that changed the event description of this previously reported event.Updated: a.4, b.5 d.6a g.3, 6 h.2, 6 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.

Manufacturer Narrative

Updated a5b updated b2 updated b5 updated b7 updated h6 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

Medtronic received additional information which stated that the patient had second degree av block which progressed to complete heart block (chb) shortly post implant of the 33mm band but was asymptomatic.It was stated that the patient then remained at "junctional rhythm." the patient had been discharged with a cardiac monitor.It was also reported that an echocardiogram showed the presence of severe sam 9 days post implant of the 33mm band and pericarditis was also observed.It was reported that there was a left ventricular outflow tract obstruction.The patient was admitted to hospital for 1 day and started on intravenous fluids.11 days post implant, the patient developed shortness of breath, fevers, nausea and was experiencing chest pain.The patient was admitted again for further evaluation and had blood cultures drawn and was administered iv antibiotics for suspected endocarditis.Blood cultures were negative.It was noted that there were no signs of a surgical site infection.It was stated that the patient experienced some premature atrial contractions as seen on a electrocardiogram.A small to moderate pericardial effusion was also reported.The 33mm band was e xplanted and replaced 15 days post implant and the posterior leaflet was reduced in height through suturing.It was reported that the 33mm device was undersized for the patients mitral valve.No additional adverse patient effects were reported.

• Brand Name: RING 620RG33 DURAN ANCORE ANNULOPLASTY C
• 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17564514
• MDR Text Key: 321341208
• Report Number: 2025587-2023-03393
• Device Sequence Number: 1
• Product Code: KRH
• UDI-Device Identifier: 00643169793484
• UDI-Public: 00643169793484
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/21/2023

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: Health Professional
• Device Model Number: 620BG33
• Device Catalogue Number: 620BG33
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 08/17/2023; 08/24/2023
• Supplement Dates FDA Received: 08/17/2023; 09/21/2023
• Date Device Manufactured: 08/10/2022
• 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; Hospitalization
• Patient Age: 47 YR
• Patient Sex: Male
• Patient Weight: 90 KG
• Patient Race: White