MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC SURGICAL TISSUE VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number MDT-TISSUE VALVE

Device Problem Insufficient Information (3190)

Patient Problems Aortic Valve Stenosis (1717); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Unspecified Infection (1930); Myocardial Infarction (1969); Sepsis (2067); Low Cardiac Output (2501); Blood Loss (2597); Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 11/28/2019

Event Type  Injury  

Manufacturer Narrative

Citation: leontyev s et al.Early and late results after david vs bentall procedure: a propensity matched analysis.Ann thorac surg.2020 jul;110(1):120-126.Doi: 10.1016/j.Athoracsur.2019.10.020.Epub 2019 nov 28.Earliest date of publish used for date of event.Medtronic products referenced: freestyle (pma# p970031, pro code lwr), mosaic (pma# p990064, pro code dye).Earliest approved product used product code and pma#.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 a comparison of the short- and long-term outcomes for patients who underwent aortic valve-sparing reimplantation (david procedure) or aortic root replacement (bentall procedure) operations.All data were retrospectively collected from a single center between january 2000 and december 2015.The study population included 523 patients (261 david procedures, 262 bentall procedures) and was predominantly male with a mean age of 53 years.Of the 262 patients who underwent a bentall procedure, 150 were implanted with medtronic devices: freestyle (55), mosaic (1), ats open pivot standard (6), and ats aortic valved graft (88).No serial numbers were provided.The overall mortality for patients requiring reoperation for valve-related events was 15.4% (4 patients).No further details were provided.Among all patients in the bentall group, the in-hospital and 30-day mortality included 4 and 5 patients, respectively.The study used non-medtronic devices in addition to the freestyle, mosaic, ats open pivot standard, and ats aortic valved graft.The type of device implanted in each patient who died was not reported.Based on the available information, medtronic product was not directly associated with any of the deaths.Among all patients in the bentall group, adverse events included: bleeding requiring hospitalization and/or reoperation; redo surgery due to endocarditis, unspecified aortic insufficiency, or aortic stenosis; new permanent pacemaker implantation; cerebrovascular accident; myocardial infarction; low cardiac output; sepsis; deep sternal wound infection; endocarditis without redo surgery; and reduced left ventricular ejection fraction.Based on the available information, medtronic product may have been associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: MEDTRONIC SURGICAL TISSUE VALVE
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• 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: 10525185
• MDR Text Key: 206770813
• Report Number: 2025587-2020-02814
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970031
• 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: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-TISSUE VALVE
• Device Catalogue Number: MDT-TISSUE VALVE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2020
• 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: 53 YR