MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC HALL PROSTHETIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number A7700

Device Problem Incomplete Coaptation (2507)

Patient Problems High Blood Pressure/ Hypertension (1908); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/01/1982

Event Type  Injury  

Manufacturer Narrative

Citation: antunes mj, et al.Intermittent aortic regurgitation following aortic valve replacement with the hall-kaster prosthesis.J thorac cardiovasc surg.1982 nov;84(5):751-4.Doi: not available.Attached full text article pdf to the report.Earliest date of publish used for date of event: november 1, 1982 (month and year valid).No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information from a literature article regarding four cases of intermittent aortic regurgitation (ar) following aortic valve replacement with the hall-kaster prosthesis.All data was collected from a single center.The study population included four patients aged 15, 21, 25, and 29 years, respectively (mean 22.5 years).A medtronic hall-kaster mechanical aortic valve was implanted in all four patients.No unique device identifier numbers were provided.Of the four patients, one died of multiple organ failure ¿several¿ (unspecified) days after the procedure.No statement was made su ggesting a causal or contributory relationship between the medtronic hall-kaster valve and the death.In all four patients, intermittent ar was identified from arterial pressure tracing, which showed an increase in the pulse pressure.In two cases, free ar was detected immediately after discontinuation of bypass.In the third, ar was diagnosed after approximation of the sternum, and in the fourth case, ar occurred a few hours after return to the intensive care unit.In all four cases, cardiopulmonary bypass was reinitiated and the aorta re-opened.Mechanical restriction of disc movement was excluded in all four cases.Then, the disc was reorientated to an alternative position.In one case, reorientation of the disc did not correct the intermittent ar, so the disc was reoriented to a third position which corrected the issue.Additionally, the authors noted a fifth patient exhibited intermittent ar at a follow-up visit several months after the hall-kaster valve implant.Examination at that time revealed ar occurring in approximately 10 to 18 heartbeats per minute.The following day, no ar was detected, despite long periods of observation.It was decided not to reoperate at that time.Per the authors, ¿we believe the mechanism of valve dysfunction relates to the position of the occluder in the open position, relative to the axis of blood flow.When the disc opens beyond the axis of flow, closure probably is not possible.The initial retrograde aortic flow maintains the disc in the open position.The intermittent nature of the dysfunction is difficult to explain, but it is probably the result of nonlaminar flow with accompanying vortices producing intermittent closure.¿ no additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC HALL PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 13022594
• MDR Text Key: 283247178
• Report Number: 2025587-2021-03764
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: P790018
• 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
• Report Date: 12/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: A7700
• Device Catalogue Number: A7700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 23 YR