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

Model Number 27VAVGJ-515

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

Patient Problems Atrial Fibrillation (1729); Hemorrhage/Bleeding (1888)

Event Date 04/28/2022

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: (b)(6), patient site id: (b)(6).It was reported that on (b)(6) 2022, a 27mm sjm masters series valsalva aortic valved graft was implanted.There were no adverse intraprocedural events reported.On (b)(6) 2022, the patient developed post-operative bleeding due to the operation.The patient was returned to surgery, and it was noted that the bleeding was coming from the graft anastomosis.The bleeding was stopped.The patient's hemoglobin was 4.6 mmol/l, and the patient received 3 units of red blood cells (rbc), 2 units of platelets, and 3 units of plasma.On (b)(6) 2022, the patient developed atrial fibrillation, which was treated with amiodarone.The atrial fibrillation resolved on (b)(6) 2022.On (b)(6) 2022, hemoglobin was 5.0 mmol/l, and the patient received one unit of rbc.On (b)(6) 2022, the patient was re-admitted to the hospital due to hypervolemia, which was treated with diuretics and was resolved by (b)(6) 2022.

Manufacturer Narrative

An event of bleeding after the implant procedure was reported.It was also reported that three days after the implant procedure the device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications information from the field indicated the bleeding was due to the operation and that the bleeding was coming from the graft anastomosis.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: 14595122
• MDR Text Key: 293290194
• Report Number: 2135147-2022-00337
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009515
• UDI-Public: 05414734009515
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: 27VAVGJ-515
• Device Catalogue Number: 27VAVGJ-515
• Device Lot Number: 7431010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2020
• 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: 38 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Race: White