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

Model Number	7700FB38
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Atrial Fibrillation (1729); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	04/19/2022
Type of Reportable Event	Serious Injury
Additional 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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that 5 days post implant of this 38mm mitral annuloplasty ring, it was explanted and replaced with a 33mm bioprosthetic valve.The reason for the replacement was not reported. no additional adverse patient effects were reported.
Additional Manufacturer Narrative
Medtronic received additional information that post repair using this 38mm mitral annuloplasty ring, severe mitral insufficiency was present and it was observed that where the posterior leaflet had been sewn back together, a tear was noted on the "p1 side".It was reported that the tear was oversewn which significantly reduced the severe insufficiency to mild residual mitral insufficiency.It was reported that the surgeon "could not interrogate the valve well" and elected to stop operating believing that the repair was adequate.It was reported that the patient developed atrial fibrillation and when the heart rate elevated or when premature atrial contractions or premature ventricular contractions with underfilling occurred, severe systolic anterior motion of the mitral valve resulting in mitral insufficiency was noted and a decision was made to explant the 38mm mitral annuloplasty ring.It was reported that during the valve replacement procedure, there were no obvious issues seen with the repair.No additional adverse patient effects were reported.A4: patients weight updated b7: relevant history updated h6: codes updated 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: SIMUPLUS
• 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: 14565944
• Report Number: 2025587-2022-01527
• Device Sequence Number: 12036076
• Product Code: KRH
• UDI-Device Identifier: 00763000271046
• UDI-Public: 00763000271046
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2022

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: 02/09/2026
• Device Model Number: 7700FB38
• Device Catalogue Number: 7700FB38
• 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: 05/06/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 06/01/2022
• Supplement Report FDA Received Date: 08/23/2022
• Date Device Manufactured: 03/02/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 92 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White