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

Model Number A7700

Device Problems Gradient Increase (1270); Obstruction of Flow (2423)

Patient Problems Corneal Pannus (1447); Aortic Regurgitation (1716); Stroke/CVA (1770); Endocarditis (1834); Blood Loss (2597); Thromboembolism (2654)

Event Date 02/01/2011

Event Type  Injury  

Manufacturer Narrative

Citation: cho yh et al.Serial changes of hemodynamic performance with medtronic hall valve in aortic position.Ann thorac surg.2011 feb;91(2):424-31.Doi: 10.1016/j.Athoracsur.2010.10.039.Earliest date of publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding the long-term hemodynamic performance after the implant of a medtronic mechanical aortic valve.All data were collected from a single center between august 1997 and january 2004.The study population included 117 patients, 55 of which were implanted with an aortic valve and 62 which were implanted with both an aortic valve and a mitral valve.Serial numbers were not provided.The study population was predominantly female; mean age 51.2 ± 10.4 years.Among all patients adverse events included: increased gradient measurements, pannus (with and without leaflet interference) and subsequent stenosis, thromboembolism, hemorrhage, re-operation, cerebral vascular accident (cva), pneumonia, valve obstruction, regurgitation, endocarditis (haemophilus influenza) and coronary artery thrombus.Based on the available information, these events may have been attributed to a medtronic product.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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8220556
• MDR Text Key: 132200945
• Report Number: 2025587-2019-00071
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2019
• 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: 12/10/2018
• 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: 51 YR