MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION HANCOCK II AORTIC BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number T505

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

Patient Problems Atrial Fibrillation (1729); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Unspecified Infection (1930); Myocardial Infarction (1969); Sepsis (2067); Transient Ischemic Attack (2109); Low Cardiac Output (2501); Blood Loss (2597)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

Citation: rocha r et al.Surgical enlargement of the aortic root does not increase the operative risk of aortic valve replacement.C irculation.2018 apr 10;137(15):1585-1594.Doi: 10.1161/circulationaha.117.030525.Epub 2017 nov 22.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 evaluate the early outcomes of patients undergoing aortic valve replacement with or without aortic root enlargement.All data were collected from a single center between january 1990 to august 2014.The study population included 1,854 patients (predominantly male, mean age 66 years), 560 of which were implanted with a medtronic hancock ii bioprosthetic valve (no serial numbers provided).Among all patients, 236 in-hospital deaths occurred.No further details were provided on these deaths.Based on the available information medtronic product was not directly associated with the death(s).Among all patients, adverse events included: bleeding requiring intervention, acute myocardial infarction (mi), low cardiac output, arrhythmia requiring permanent pacemaker implant, sternal wound infection, sepsis, atrial fibrillation, stroke, transient ischemic attack (tia).Based on the available information medtronic product may have been associated with the adverse event(s).No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK II AORTIC BIOPROSTHETIC HEART 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: 8925651
• MDR Text Key: 155355182
• Report Number: 2025587-2019-02638
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P980043
• 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: 08/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T505
• Device Catalogue Number: T505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 08/23/2019
• 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): Life Threatening; Required Intervention
• Patient Age: 66 YR