MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE WITH FLEX CUFF; HEART-VALVE, MECHANICAL

Model Number	AGFN-756
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Adult Respiratory Distress Syndrome (1696); Sepsis (2067)
Date of Event	12/01/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
The abstract article, "trifecta bioprostheses: evaluation of the safety based on the study of degenerations according to the varc-3 classification", was reviewed.The research article is a retrospective single center experience to evaluate the intrinsic imputability of trifecta for dysfunction according to the varc-3 classification in patients implanted and to reassess their referencing in our center.Trifecta valve was the device associated with this study.The article concluded, the classification of failures according to varc-3 indicated the intrinsic imputability of the trifecta¿ bioprostheses regarding to the number of svd-type dysfunctions.Although this study has limitations, it shows the understatement of medical-devices-vigilance cases by the medical staff.[the primary author of this article is richez, ophelie, amiens-picardie university hospital, 1 rond-point du professeur christian cabrol, 80054 amiens, france, with email address of : richez.Ophelie@chu-amiens.Fr].It was reported that on an unknown date in february of 2013, a 23mm trifecta valve was implanted for native valve endocarditis of a 37 year old patient.The trifecta was implanted at the aortic and the perimount at the mitral valve.In april of 2021, it was reported dyspnea progressively increased during the 3 to 4 months and the aortic valve showed a stenosant image and central aortic leak grade 1.In may of 2021, a bioprothesis degeneracy was reported.In june of 2021, an aortic prothesis degeneracy was reported and a reoperation was necessary.On july 2021, ultrasound showed the left ventricle ejection fraction of 55%, slightly dilated left ventricle, inferiror vena cava vein dilated but compliant.There was also grade 1 tricuspid leak, stenosis noted on aortic prosthesis and leakage with a gradient of 86 mmhg.In august of 2021, the trifecta valve was replaced with a 21 mm sjm regent heart valve w/flex cuff.The removed trifecta valve was totally destroyed and calcified, and the patient suffered with multiple post-surgical complications.In december 2021, the patient passed due to a cardiogenic and septic shock due to massive inhalation at the second coma, refractory to any therapy, with serious mixt sdra (acute respiratory distress syndrome).Cn-165472 : this event is being conservatively reported as the relationship to the regent valve is unknown.
Additional Manufacturer Narrative
An event of death post implant procedure was reported.Information from the field indicated that a trifecta valve was replaced with a regent mechanical heart valve and the patient died a few months after the procedure.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported incident of death was due to cardiogenic and septic shock due to massive inhalation at the second coma, refractory to any therapy, with serious mixt sdra (acute respiratory distress syndrome).However, the relationship to the regent valve is unknown.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: REGENT HEART VALVE WITH FLEX CUFF
• Common Device Name: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16858592
• Report Number: 2135147-2023-01919
• Device Sequence Number: 6770937
• Product Code: LWQ
• UDI-Device Identifier: 05414734005975
• UDI-Public: 05414734005975
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P810002
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2023

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: 06/13/2026
• Device Model Number: AGFN-756
• Device Catalogue Number: 21AGFN-756
• Device Lot Number: 8014312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 06/16/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 07/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2021
• 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: Death
• Patient Age: 37 YR
• Patient Sex: Unknown