MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION RING 620RG27 DURAN ANCORE ANNULOPLASTY C; RING, ANNULOPLASTY

Model Number	620RG27
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Patient Device Interaction Problem (4001); Intravalvular regurgitation (4068)
Health Effect - Clinical Codes	Abdominal Pain (1685); Cardiac Arrest (1762); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Pleural Effusion (2010); Cardiogenic Shock (2262); Mitral Valve Insufficiency/ Regurgitation (4451); Insufficient Information (4580)
Date of Event	12/03/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received information that 21 days post implant of this 27mm mitral annuloplasty ring, it was explanted and replaced with a 31mm mitral bioprosthetic valve.The reason for the replacement was not reported.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Updated a4 updated a5b updated b2 updated b5 updated b7 updated h6.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
Medtronic received additional information which stated that the patient was admitted to the hospital in cardiac arrest with cardiogenic shock.It was stated that the patient had earlier experienced difficulties breathing and abdominal pain.It was reported that the patient was asystolic and also experienced pulseless electrical activity (pea).Cardiopulmonary resuscitation (cpr) was performed.The patient was stabilized and transferred to the icu.During the patients stay, they continued to arrest and was hypotensive and required vasopressors, inotropic and ventilatory support.The patient had severe lactic acidosis.It was stated that severe mitral regurgitation and dehiscence of the mitral ring was observed on a echocardiogram.A computed tomography (ct) scan of the abdomen and pelvis was performed and revealed pulmonary congestion/edema, a moderate right sided pleural effusion, abnormal hepatic architecture suggestive for hypoperfusion, wedge shape infarcts of both kidneys, thickened gallbladder wall, and ascites.An exploratory laparotomy and replacement of the mitral valve procedure was undertaken.It was noted that intra-operatively, the patient's bowel was found to be without any definitive ischemic or necrotic areas.The mitral ring was explanted and replaced with a valve.The patient required multiple units of packed red blood cells (prbcs), cryoprecipitate, platelets and fresh frozen plasma (ffp) for acute surgical blood loss anemia.Post-operatively, the patient required placement of an dialysis catheter for continuous veno-venous hemofiltration (cvvh) secondary to acute renal failure.It was reported that despite multiple efforts at sustaining life, the patient's multiple organ failure, secondary to profound shock, was irreversible.The patient died the following day.It was indicated that an autopsy was not performed.

• Brand Name: RING 620RG27 DURAN ANCORE ANNULOPLASTY C
• 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: 18996287
• Report Number: 2025587-2024-01972
• Device Sequence Number: 19605243
• Product Code: KRH
• UDI-Device Identifier: 00613994758941
• UDI-Public: 00613994758941
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K032810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2024

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: 07/22/2016
• Device Model Number: 620RG27
• Device Catalogue Number: 620RG27
• 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: 03/25/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/10/2024
• Date Device Manufactured: 08/10/2011
• 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; Life Threatening
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 86 KG
• Patient Race: White