MAUDE Adverse Event Report: ABBOTT MEDICAL REGENT HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 19AGN-751

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

Patient Problems Transient Ischemic Attack (2109); Blurred Vision (2137)

Event Type  Injury  

Event Description

An article from the heart's original "aortic valve replacement complicated postoperatively by acute angle closure glaucoma", reported a case 65-year-old male with a history of cardiac murmur who underwent cardiac catheterization.No anomaly for coronary arteries was pointed out.Although aortic stenosis was confirmed, pressure gradient between left ventricle and aorta was 23mmhg.The patient was scheduled to followed in outpatient clinic 2 years ago on an unknown date.On an unknown date, the patient was admitted to hospital for chest discomfort noted while he was playing baseball.The echocardiography confirmed 4m/s aortic valve blood velocity and aortic stenosis.St elevation on v1-3 and left ventricle hypertrophy was detected by electrocardiogram.In addition, cardiac enzyme elevation was observed.The patient was treated internally and once the symptom was stable, cardiac catheterization was performed again.Pg (pressure-gradient) increased up to 56mmhg and aortic stenosis progress was confirmed.One month later, avr (aortic valve replacement) was conducted.A 19mm sjm regent valve was implanted in aortic position.The patient complained numbness left lower extremity and difficult movement of right fingers on the 3rd operative day.Cerebral ischemia attack was suspected, and treatment was started though, mydriasis and marked failing vision was confirmed on the 4th operative day.The patient had an examination by an ophthalmologist.Elevation of intraocular pressure (40-50mmhg) was confirmed, and acute glaucoma attack was diagnosed.Ocular instillation of pilocarpine hydrochloride did not obtain decreased ocular pressure.Laser iridectomy was conducted on the same date.Intraocular pressure returned to normal range and the patient's visual performance remained.No further information is available.[the primary author and corresponding author of this article is tochigi, shuichi, md, 2-chome-16-7 yanaka adachi city, tokyo 120-0006 japan].

Manufacturer Narrative

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

Manufacturer Narrative

An event of cerebral ischemia attack and acute glaucoma attack a few days after the implant of a regent valve was reported through a literature article.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or additional patient information was received for analysis.The cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: REGENT HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG#3007113487; 177 county road b east; st. paul MN 55117 1789
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 15651941
• MDR Text Key: 302257163
• Report Number: 2135147-2022-01727
• Device Sequence Number: 1
• Product Code: LWQ
• UDI-Device Identifier: 05414734005869
• UDI-Public: 05414734005869
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P810002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 19AGN-751
• Device Catalogue Number: 19AGN-751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 72 KG