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

Model Number	7700FB32
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Stroke/CVA (1770); Thrombosis/Thrombus (4440)
Date of Event	04/16/2023
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.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.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 32mm mitral annuloplasty band, the patient experienced an ischemic stroke.It was stated that the patient first presented with sudden onset left-sided weakness and left facial droop.It was reported that a right superior m2 occlusion was discovered.It was stated that the following day, the patient symptoms included left facial droop, dysarthria, left arm weakness, left leg drift, and left sided sensation change.It was reported that computed tomography (ct) imaging showed right superior m2 occlusion due to the presence of a thrombus in a right m2 segment of the middle cerbral artery branch, perfusion defect in the frontotemporal region compatible with ischemia with penumbra without the presence of core infarct and subtle early ischemic changes in the right sub insular and right frontal regions.A thrombectomy was performed.It was mentioned that the patient did not have a prior history of strokes.It was reported that the patient has recovered.No additional adverse patient effects were reported.

• 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: 16885821
• Report Number: 2025587-2023-01972
• Device Sequence Number: 20356421
• Product Code: KRH
• UDI-Device Identifier: 00763000271015
• UDI-Public: 00763000271015
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K201449
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/08/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/07/2026
• Device Model Number: 7700FB32
• Device Catalogue Number: 7700FB32
• 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: 04/17/2023
• Initial Report FDA Received Date: 05/08/2023
• Date Device Manufactured: 01/15/2021
• 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: 61 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White