MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION SIMULUS SEMI-RIGID ANNULOPASTY RING; RING, ANNULOPLASTY

Model Number	800SR34
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Respiratory Failure (2484); Pericardial Effusion (3271); Unspecified Nervous System Problem (4426)
Date of Event	09/29/2021
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that this mitral annuloplasty device was implanted to repair the patient's native mitral valve.It was reported that the patient "did not wake up properly after the surgery" and that an acute stroke could not be ruled out.It was reported that the patient had "critical illness" and polyneuropathy.Later in the day, the patient developed a pericardial effusion.A re-do thoracotomy was performed to treat the effusion.Following the re-do thoracotomy, echocardiogram revealed a mild pericardial effusion.Two days post surgery, neurological evaluation revealed no signs of acute stroke and echocardiogram on the same date showed no pericardial effusion.It was reported that the surgeon believed the pericardial effusion and neurological issues both had a "possible" relation to the annuloplasty device and a "probable" relationship to the original procedure.Twenty-three (23) days following the mitral valve repair surgery, the patient received a tracheostomy for long-term ventilation.No additional adverse patient effects were reported.

• Brand Name: SIMULUS SEMI-RIGID ANNULOPASTY RING
• 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: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 12901943
• Report Number: 2025587-2021-03609
• Device Sequence Number: 4827678
• Product Code: KRH
• UDI-Device Identifier: 00643169182264
• UDI-Public: 00643169182264
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072655
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/30/2021

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: 02/08/2026
• Device Model Number: 800SR34
• Device Catalogue Number: 800SR34
• 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: 11/03/2021
• Initial Report FDA Received Date: 11/30/2021
• 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; Life Threatening; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 52 KG