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

Model Number T505

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Atrial Fibrillation (1729); Non specific EKG/ECG Changes (1817); Unspecified Infection (1930)

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

Title: medtronic freestyle aortic bioprosthesis: a potential option for haemodialysis patients citation: interactive cardiovascular thoracic surgery.2016 apr; 22(4):459-63 (doi 10.1093/icvts/ivv388) authors: yasser y.Hegazy, amr rayan, ralf sodian,wael hassanein and jürgen ennker earliest date of e-publish/publish used for event date.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding the implant and performance of freestyle (fs) and stented bioprosthetic aortic valve (non freestyle (that had been implanted into patients undergoing hemodialysis for end stage renal disease.All data were collected from a single center between 2007 and 2013.The study population included 84 patients (predominantly male; mean age (76.4 ± 8.1 vs 74.9 ± 7.2 years).Thirty-six patients were implant with one of two types of stented bioprosthetic aortic valves, a hancock ii or a non medtronic valve.Forty-eight were implanted with a freestyle stentless aortic bioprosthesis (serial numbers not provided).Among all patients implanted with a stented aortic bioprosthesis adverse events included: 15 incidents of atrial fibrillation, 3 incidents of ¿re-exploration¿, increased gradient measurement of 14.1 ± 4.1 mm hg, 1 incident of permanent pacemaker implant, 1 incidents of deep sternal wound infection, 9 incidents of calcification or sclerosis, and 3 incidents of an unspecified "neurological disorder" multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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: 6143918
• MDR Text Key: 61398081
• Report Number: 2025587-2016-01916
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P980043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2016
• 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
• Date Manufacturer Received: 11/17/2016
• 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: 76 YR