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

Model Number 27CAVGJ-514 00

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

Patient Problems Stroke/CVA (1770); Brain Injury (2219); Respiratory Insufficiency (4462); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/25/2022

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, a 27mm masters aortic valved graft was successfully implanted.There were no intraprocedural adverse events.On (b)(6) 2022, patient's c-reactive protein was 237.3 mg/l.On (b)(6) 2022, the patient had a severe ischemic stroke with mrs score of 5.The patient was unconscious with no noticeable reaction to stimuli and no reflexes.The patient had left-sided paresis.A computed tomography (ct) scan revealed acute ischemic changes and a swelling of almost the entire right hemisphere of the brain.The patient was intubated and placed on mechanical ventilation.Medications including antibiotics, antifungal, narcotics, diuretics, sedatives, beta blockers, and anticoagulants were administered.On (b)(6) 2022, the patient was discharged from the implant site hospital and transferred to another hospital.The patient's symptoms were ongoing at time of transfer.There were no device deficiencies reported.No additional information was provided.

Manufacturer Narrative

An event of ischemic stroke five days after the implant procedure 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 the 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.H6 health effect - clinical code 4581 removed and 2219 added.

Manufacturer Narrative

An event of ischemic stroke five days after the valve implant procedure and patient death about one month after the implant procedure 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 the 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.H6.Health effect - clinical code : removed code 4581 appropriate term / code not available.

Event Description

It was reported that on (b)(6) 2022, a 27mm masters aortic valved graft was successfully implanted.There were no intraprocedural adverse events.On (b)(6) 2022, patient's c-reactive protein was 237.3 mg/l.On (b)(6) 2022, the patient had a severe ischemic stroke with mrs score of 5.The patient was unconscious with no noticeable reaction to stimuli and no reflexes.The patient had left-sided paresis.A computed tomography (ct) scan revealed acute ischemic changes and a swelling of almost the entire right hemisphere of the brain.The patient was intubated and placed on mechanical ventilation.Medications including antibiotics, antifungal, narcotics, diuretics, sedatives, beta blockers, and anticoagulants were administered.On (b)(6) 2022, the patient was discharged from the implant site hospital and transferred to another hospital.The patient's symptoms were ongoing at time of transfer.There were no device deficiencies reported.Subsequent to the previously filed report, additional information was received that the patient died on (b)(6) 2022 in the intensive care unit.

Manufacturer Narrative

An event of ischemic stroke five days after the valve implant procedure and patient death about one month after the implant procedure 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.The exact cause of death was unknown but was likely related to the ischemic stroke and patients clinical condition.It was unknown if the stroke was procedure or device related.Based on the information received, the cause of the 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.

Event Description

N/a.

• Brand Name: MASTERS SERIES HEART COATED AORTIC VALVED 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: 14217124
• MDR Text Key: 290143822
• Report Number: 2135147-2022-00226
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734006422
• UDI-Public: 05414734006422
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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,Followup,Followup
• Report Date: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27CAVGJ-514 00
• Device Catalogue Number: 27CAVGJ-514 00
• Device Lot Number: 8266191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2021
• 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): Life Threatening; Disability; Death; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White