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

Model Number 995

Device Problem Calcified (1077)

Patient Problems Aortic Valve Stenosis (1717); Infarction, Cerebral (1771); Congestive Heart Failure (1783); Death (1802); Embolism (1829); Endocarditis (1834); Renal Failure (2041); Sepsis (2067); Complete Heart Block (2627); Multiple Organ Failure (3261)

Event Date 07/15/2013

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).Title of article: freestyle root replacement for complex destructive aortic valve endocarditis citation: j thorac cardiovasc surg 10.1016/j.Jtcvs.2013.05.014 issue number: 147:1265-70 authors: anneliese heinz, md, julia dumfarth, md, elfriede ruttmann-ulmer, md, michael grimm, md, and ludwig c.M¿uller, md.The available ahead of print date (b)(6) 2013 used for event date.

Event Description

Medtronic received information via literature review that a study was performed over a 10 year period to evaluate freestyle aortic root replacement for severe, destructive valve endocarditis.The study population included 32 patients, predominantly male with a mean age of 61 years, all of whom were implanted with medtronic freestyle aortic root replacement (serial numbers not provided).Among all patients, 14 deaths occurred, which included: multi-organ failure, cardiac decompensation, ischemic heart failure, acute cardiac death, acute myocardial infarction, unexplained sudden death, brainstem infarction, staphylococcus sepsis, and unknown reasons.Of these deaths, none were directly associated with / attributed to the valve or its function.Among all patients, 19 adverse events occurred, which included: reoperation for bleeding due to coagulopathy, postoperative mechanical circulatory support with intra-aortic balloon pump and extracorporeal membrane oxygenation, permanent pacemaker for new heart block, temporary hemo- filtration for new-onset acute renal failure, ischemic stroke caused by multiple embolic lesions of different age.Three (3) patients underwent reoperation: one (1) after 3 years and 1 after 12 years for xenograft degeneration due to severe calcific stenosis and 1 after 3 years for recurrent endocarditis.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): HEART VALVES SANTA ANA; 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: 5335531
• MDR Text Key: 34691285
• Report Number: 2025587-2015-01418
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995
• Device Catalogue Number: 995
• 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: 00061 YR