MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number FR995-25

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

Patient Problems Aortic Regurgitation (1716); Stroke/CVA (1770); Non specific EKG/ECG Changes (1817); Unspecified Infection (1930); Renal Failure (2041); Cardiac Tamponade (2226)

Event Date 06/01/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: hemodynamic performance and outcome of percutaneous versus surgical stentless bioprostheses for aortic stenosis with anticipated patient¿prosthesis mismatch citation: the journal of thoracic and cardiovascular surgery volume 147, issue 6, pages 1892¿1899 authors: arie finkelstein, md, arie lorin schwartz, md, gideon uretzky, md, shmuel banai, md, gad keren, md, amir kramer, md, and yan topilsky, md month and year of publish were 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.

Event Description

Medtronic received information via literature review that a study was performed to evaluate early and midterm hemodynamic performance and outcomes after the implant of a surgical stentless bioprosthesis or a percutaneous bioprosthesis with anticipated patient prosthesis mismatch.The study population included 135 patients (predominantly female; mean age 79 +/- 7 years).All patients in the savr group (49) received a medtronic freestyle device.Patients in the tavr group (86) received either a corevalve device or a non-medtronic device (serial numbers were not reported).Across all patients, 4 in-hospital deaths occurred (3 tavr and 1 savr).The article does not indicate a direct relationship between the valve implant/function and the deaths.There was no allegation against the valve or its function nor was there any allegation that the valve contributed to the patient deaths.Across all savr patients, adverse events included; 1 incident of electrocardiogram (ecg) changes that required a permanent pacemaker implant, 1 incident of cerebral vascular accident (cva), 1 incident of cardiac tamponade, 4 incidents of acute renal failure, 3 incidents of infection, 7 incidents of mild aortic regurgitation and 44 incidents of patient prosthesis mismatch.Other than the permanent pacemaker implant, the treatment for the adverse events was not provided.Across all tavr patients, adverse events included; 14 incidents of electrocardiogram (ecg) changes that required a permanent pacemaker implant, 2 incidents of cerebral vascular accident (cva), 2 incidents of cardiac tamponade, 3 incidents of acute renal failure, 10 incidents of infection 61 incidents of mild paravalvular leak (pvl) and 20 incidents of patient prosthesis mismatch.Other than the permanent pacemaker implant, the treatment for the adverse events was not provided.No additional adverse patient effects were reported.

Manufacturer Narrative

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

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5332768
• MDR Text Key: 34613244
• Report Number: 2025587-2015-01414
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FR995-25
• Device Catalogue Number: FR995-25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: No
• 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: 00079 YR