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

Catalog Number 25VAVGJ-515

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888); Respiratory Insufficiency (4462)

Event Date 01/11/2024

Event Type  Injury  

Manufacturer Narrative

An event of a drop in hemoglobin, respiratory failure, and likely atelectasis was 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 event could not conclusively be determined.There was no allegation of malfunction against the abbott device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

Event Description

Crd_992 - valved grafts pas us0056-820 (r821146601, r821157001) it was reported that on (b)(6) 2024, a 25mm master series,vavgj was implanted in a patient.Baseline hemoglobin=13.7 hematocrit= 37.9 preop; intra operative hemoglobin dropped to 6.8, hematocrit=21.Therefore, the patient was transfused with packed red blood cells and platelets.Patient course remained anemic, which required several blood transfusions of packed red blood cells.It was also noted that patient had respiratory failure, likely atelectasis, and a pigtail was placed.On (b)(6) 2024, the patient was reintubated and then extubated on (b)(6) 2024.The patient was off all vasoactive with no reported issues.The patient was reported to be in stable condition.

Event Description

Clinical information: (b)(6) - valved grafts pas, patient site id: (b)(6).It was reported that on (b)(6) 2024, a 25mm sjm masters series valsalva aortic valved graft was implanted in a patient.Prior to procedure, the patient's baseline hemoglobin was 13.7 and hematocrit was 37.9.Intraoperatively, hemoglobin dropped to 6.8 and hematocrit to 21.Therefore, the patient was transfused with packed red blood cells and platelets.Patient remained anemic and required several blood transfusions of packed red blood cells on (b)(6) 2024.It was also noted that patient had respiratory failure, likely atelectasis.On (b)(6) 2024, the patient was reintubated and a pigtail was placed.On (b)(6) 2024, the patient was extubated.The patient was off all vasoactive with no reported issues.On (b)(6) 2024, it was noted that the patient returned to the emergency department due to being tachycardic and had developed rapid atrial fibrillation.The decision was made to administer the patient a total of 20mg of cardizem, and the patient was hospitalized.On (b)(6) 2024, the patient received another blood transfusions of red blood cells.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of a drop in hemoglobin, respiratory failure, atelectasis and rapid atrial fibrillation was 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 event could not conclusively be determined.There was no allegation of malfunction against the abbott device.There is no indication of a product quality issue with regards to manufacture, design, or labeling.H6 health effect - clinical code: code 1888 removed.

• 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: 18603254
• MDR Text Key: 334040483
• Report Number: 2135147-2024-00401
• 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
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 25VAVGJ-515
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: No
• 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; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White