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

Model Number 995

Device Problem Gradient Increase (1270)

Patient Problems Endocarditis (1834); Unspecified Infection (1930); Myocardial Infarction (1969)

Event Date 01/19/2016

Event Type  Injury  

Manufacturer Narrative

A.Schneider et al."stentless bioprostheses: a versatile and durable solution in extensive aortic valve endocarditis" european journal of cardio-thoracic surgery 49 (2016) 1699¿1704.Doi:10.1093/ejcts/ezv463 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.(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 regarding outcomes following stentless bioprosthesis implant in patients with infective endocarditis of the aortic valve with root destruction.All data was collected from a single center between june 2000 and december 2014.The study population included 54 patients (predominantly male; mean age 61 years), all of which were implanted with a medtronic freestyle valve (serial numbers were not provided).The literature reported 13 deaths which occurred due to: myocardial infarction (mi), multi-organ failure, left ventricle failure, right ventricle failure, respiratory insufficiency, intestinal ischemia, congestive heart failure (chf), sepsis, urosepsis, lymphoma, and pancreatic cancer.One patient was reported to expire from postanoxic encephalopathy following cardiac arrest.Based on the available information, none of the deaths were attributed to a medtronic product.Among all patient¿s adverse events included: mild aortic regurgitation, elevated gradients, 6 renal failure, 5 patients required reoperation for bleeding, and 13 required permanent pacemaker implant.One case of recurrent postoperative endocarditis was reported 2.3 years following.The infection grew a pneumococcus strain which involved the left main coronary artery, roof of the left atrium, left atrial appendage and anterior mitral valve leaflet.Subsequently, the patient required reconstruction with a second freestyle valve implant.The patient was prescribed antibiotic therapy and recovered.No additional adverse patient effects were reported.

Event Description

Additional information received from the physician/author stated that medtronic product did not cause or contribute to any of the observed deaths or adverse events, and also provided the freestyle model 995 (no serial numbers provided) and the patient mean weight of 83.5 kg.

Manufacturer Narrative

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.

• 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 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: 6487155
• MDR Text Key: 72619076
• Report Number: 2025587-2017-00566
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2017
• 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?: No
• Date Manufacturer Received: 05/16/2017
• 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): Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Weight: 84