MAUDE Adverse Event Report: ABBOTT MEDICAL MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT; HEART-VALVE, MECHANICAL

Catalog Number 27VAVGJ-515

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pleural Effusion (2010); Shock (2072); Electrolyte Imbalance (2196)

Event Date 09/20/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6) it was reported that on (b)(6) 2023, a 27mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.There was no difficulty experienced implanting the 27mm sjm masters series valsalva aortic valved graft.The patient had remained hemodynamically stable throughout the implant procedure.There was no clinically significant delay in procedure reported.It was noted post-procedure that the patient had an onset of vasoplagic shock and lactic acidosis.It was also noted post-procedure, that the patient's white blood cell count was at a minimum of 11.0 and a max of 16.0.The patient required volume resuscitation.On (b)(6) 2023, the patient developed acute hypokalemia and required an electrolyte replacement.There was no initial or prolonged hospitalization due to these events.It's believed that the cause of the patient's post-procedure vasoplagic shock and lactic acidosis is due to the cardiopulmonary bypass during procedure.The patient's acute hypokalemia is due to a planned post-operative diuresis.There is no allegation of malfunction against the abbott device or procedure.The patient was stable, recovered, and discharged at the time of report.

Manufacturer Narrative

An event of shock and electrolyte inbalance were reported.A returned device inspection could not be performed as the device was not returned for analysis.Based on the available information, the root cause of the reported events appeared to be related to procedural conditions.Reportedly, it's believed that the cause of the patient's post-procedure vasoplagic shock and lactic acidosis is due to the cardiopulmonary bypass during procedure.The patient's acute hypokalemia is due to a planned post-operative diuresis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

Clinical information: crd_992 - valved grafts pas, patient site id: (b)(6) ((b)(6), (b)(6), (b)(6)) it was reported that on (b)(6)2023, a 27mm sjm masters series valsalva aortic valved graft was successfully implanted in a patient.There was no difficulty experienced implanting the 27mm sjm masters series valsalva aortic valved graft.The patient had remained hemodynamically stable throughout the implant procedure.There was no clinically significant delay in procedure reported.It was noted post-procedure that the patient had an onset of vasoplagic shock and lactic acidosis.It was also noted post-procedure, that the patient's white blood cell count was at a minimum of 11.0 and a max of 16.0.The patient required volume resuscitation.On (b)(6)2023, the patient developed acute hypokalemia and required an electrolyte replacement.There was no initial or prolonged hospitalization due to these events.It's believed that the cause of the patient's post-procedure vasoplagic shock and lactic acidosis is due to the cardiopulmonary bypass during procedure.The patient's acute hypokalemia is due to a planned post-operative diuresis.There is no allegation of malfunction against the abbott device or procedure.The patient was stable, recovered, and discharged at the time of report.Subsequent to the previously filed report, additional information was received that on (b)(6)2023, a moderate pleural effusion was seen on chest x-ray.A thoracentesis was performed at bedside, and 1l was drained.A repeat chest x-ray showed resolution of the effusion.

Manufacturer Narrative

Additional information: b5, h6 an event of pleural effusion, shock, and electrolyte imbalance were reported.A returned device inspection could not be performed as the device was not returned for analysis.Based on the available information, the root cause of the reported events appeared to be related to procedural conditions.Reportedly, it's believed that the cause of the patient's post-procedure vasoplagic shock and lactic acidosis is due to the cardiopulmonary bypass during procedure.The patient's acute hypokalemia is due to a planned post-operative diuresis.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: MASTERS SERIES HEART VALSALVA AORTIC VALVES GRAFT
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL PUERTO RICO, INC. REG#2648612; 20 b st caguas west park; caguas 00725 ; * 00725
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18499528
• MDR Text Key: 332724068
• Report Number: 2135147-2024-00219
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 8913670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/11/2024
• Supplement Dates Manufacturer Received: 01/16/2024; 03/05/2024
• Supplement Dates FDA Received: 01/18/2024; 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 112 KG
• Patient Race: White