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

Model Number 25VAVGJ-515

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

Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)

Event Date 11/13/2022

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 study patient id: (b)(6).It was reported that on (b)(6) 2022, a 25mm masters valve was selected for an implant.Intra-operative bleeding was noted due to complex surgical repair.Post-implant, the patient was transfused 2 units pack red blood cells (prbc), 6 units platelets and 6 units plasma.Heparin was administered with the following activated clotting time (act) levels act's: at 19:45 112 seconds , at 21:15 467 seconds , at 21:30 487 seconds , at 21:45 720 seconds , at 22:15 632 seconds, at 22:45 536 seconds, at 23:45 123 seconds.The patient's international normalized ratio (inr) was pre-op on (b)(6) 1.1, post-op on (b)(6) 1.2, at discharge on (b)(6) 2.5, current on (b)(6) 2.7.The issue was reported to be resolved with sequelae of blood loss anemia with no further treatment planned.The patient remained hemodynamically stable throughout the procedure.The patient was reported to have been discharged home in stable condition.

Manufacturer Narrative

An event of intra-operative bleeding due to complex surgical repair was reported.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 reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 15895245
• MDR Text Key: 304629397
• Report Number: 2135147-2022-02295
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734009492
• UDI-Public: 05414734009492
• 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: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2023
• Device Model Number: 25VAVGJ-515
• Device Catalogue Number: 25VAVGJ-515
• Device Lot Number: 8064302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 50 KG
• Patient Race: White