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

Model Number T510

Device Problem Structural Problem (2506)

Patient Problems Stroke/CVA (1770); Death (1802); Endocarditis (1834); Hemolysis (1886); Hemorrhage/Bleeding (1888); Thrombosis (2100); Transient Ischemic Attack (2109)

Event Date 02/01/2001

Event Type  Death  

Manufacturer Narrative

Citation: david et al.Late results of heart valve replacement with the hancock ii bioprosthesis.J thorac cardiovasc surg.2001 fe b;121(2):268-77.Doi:10.1067/mtc.2001.112208.Earliest date of publish used for event date and date of death.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 for aortic or mitral valve replacement with the hancock ii bioprosthesis.All data were collected from two toronto centers between september 1982 and december 1994.The study population included 980 patients (predominantly male, mean age 65 years) implanted with medtronic hancock ii bioprosthetic valve (no serial numbers provided) in the aortic (n=670) or mitral position (n=310).Among all patients 32 operative and 208 late deaths occurred with the aortic group, and 25 operative and 124 late deaths occurred in the mitral group.Among the late deaths, 28 and 24 were deemed valve-related in the aortic and mitral groups, respectively.Valve -related death was defined as death from structural valve dysfunction, stroke, transient ischemic attack, prosthetic valve endocarditis, reoperation on the bioprosthetic valve, anticoagulant-related hemorrhage, valve thrombosis, or hemolysis.No details were provided on any of these deaths.Based on the available information medtronic product was directly associated with the valve-related deaths.Among all patients, adverse events included: structural valve dysfunction, stroke, transient ischemic attack, prosthetic valve endoc arditis, reoperation on the bioprosthetic valve, hemorrhagic complications, valve thrombosis, and hemolysis.Based on the available information medtronic product was directly associated with the adverse events.No additional adverse patient effects or product performance issues were reported.

• Brand Name: HANCOCK II MITRAL 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: 8652396
• MDR Text Key: 146469661
• Report Number: 2025587-2019-01732
• 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: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: T510
• Device Catalogue Number: T510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2019
• 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): Death; Life Threatening; Required Intervention
• Patient Age: 65 YR