MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING ANNULOPLSTY TRICUSP CONTOUR 3D 36MM; RING, ANNULOPLASTY

Model Number	690R36
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Bradycardia (1751); Non specific EKG/ECG Changes (1817)
Date of Event	10/25/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Conduction disturbances are known potential adverse effects associated with any cardiac or thoracic procedure (open or catheter-based) and can be resolved with medical treatment or the implant of a permanent pacemaker (with the risk-benefit ratio in favor of implant of the percutaneous aortic valve).A conduction disturbance does not indicate a device malfunction or potential manufacturing issue.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 6 days following the implant of this tricuspid annuloplasty band, the patient developed bradycardia with heart rate reported as 26 beats per minute (bpm).It was reported that 1 day later, a permanent pacemaker was implanted.It was also reported that the discharge electrocardiogram (ecg) performed noted widened qrs complexes and left bundle branch block (lbbb).No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information stating the reason for pacemaker implantation was due to symptomatic long pauses (6 seconds) with bradycardia and atrial fibrillation.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: RING ANNULOPLSTY TRICUSP CONTOUR 3D 36MM
• Common Device Name: 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: 13353097
• Report Number: 2025587-2022-00202
• Device Sequence Number: 4646245
• Product Code: KRH
• UDI-Device Identifier: 00643169121720
• UDI-Public: 00643169121720
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/06/2026
• Device Model Number: 690R36
• Device Catalogue Number: 690R36
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2021
• Supplement Date Received by Manufacturer: 09/08/2022
• Initial Report FDA Received Date: 01/25/2022
• Supplement Report FDA Received Date: 09/23/2022
• Date Device Manufactured: 07/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 95 KG