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

Model Number A7700

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Host-Tissue Reaction (1297); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage/Bleeding (1888); Tricuspid Regurgitation (2112); Thromboembolism (2654)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Citation: heemoon lee, late clinical outcomes after mechanical aortic valve replacement for aortic stenosis: old versus new prostheses j thorac dis.2018 jun; 10(6): 3361¿3371doi: 10.21037/jtd.2018.06.03 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.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 via literature regarding late clinical outcomes of new-generation mechanical valves for severe aortic stenosis (as) compared with old mechanical valves.All data were collected from a single center between january 1995 and december 2013.The study population included 254 patients (predominantly male, median age 59 years), 33 patients were implanted with medtronic ats open pivot mechanical heart valve and 32 patients were implanted with med hall easy-fit mechanical heart valve.No serial numbers were provided.Among all patients, there were 28 late deaths reported in both study groups combined.The causes of death included cerebral hemorrhage in three, cerebral infarction in two, alveolar hemorrhage in one, heart failure in one, ischemic cardiomyopathy in one, sudden death in one, cancer in six, aging in one, and unknown in ten patients.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between medtronic product and the observed adverse events.Among all patients, adverse events included: bleeding requiring reoperation (n=2), permanent pacemaker implantation (n=1), thromboem bolic events, prosthesis-patient mismatch (n=12), infective endocarditis (n=3), pannus formation (n=2) and trisucpid regurgitation.Based on the available information, medtronic product may have caused or contributed to these adverse events.Among all patients, 1 device malfunction was reported in the old-valve group of patients who received ats standard and 32- med hall valves.The device malfunction was not specifically attributed to a particular medtronic product.Therefore, conservatively choosing to report the malfunction on both the product groups.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: 8130261
• MDR Text Key: 129298096
• Report Number: 2025587-2018-03293
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• 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: 11/12/2018
• 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: 59 YR