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

Model Number FR99529

Device Problems Gradient Increase (1270); Perivalvular Leak (1457); Incomplete Coaptation (2507); Torn Material (3024)

Patient Problems Host-Tissue Reaction (1297); Aortic Regurgitation (1716); Stroke/CVA (1770); Endocarditis (1834); Unspecified Infection (1930); Blood Loss (2597)

Event Date 01/01/2009

Event Type  Injury  

Manufacturer Narrative

Citation: jurgen a.C.Ennker.The freestyle stentless bioprosthesis in more than 1000 patients: a single-center experience over 10 years.Journal of cardiac surgery.2009 jan-feb; 24(1): 41-48.Doi: 10.1111/j.1540-8191.2008.00732.X.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the freestyle stentless bioprosthesis in more than 1000 patients.  all data were collected from a single center between 1996 and 2005. the study population included 1014 patients (predominantly male; mean age 73 years), all of which were implanted with medtronic freestyle (serial numbers not provided).  among all patients adverse events included: reoperations due to structural valve deterioration, paravalvular leak (pvl), pannus formation, unacceptable hemodynamics, incompetent valve due to dilation of sinotubular junction, increased gradient of 30 mmhg, cusp rupture, pericarditis following myocardial infarction (mi), endocarditis, and stiffening of the cusps due to inflammation.Bleeding and neurological events were also reported.Based on the available information, it was unable to determine relatedness to the medtronic product.  no additional adverse patient effects were reported.

• Brand Name: FREESTYLE
• 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: 7455472
• MDR Text Key: 106331420
• Report Number: 2025587-2018-00961
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 04/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FR99529
• Device Catalogue Number: FR99529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/24/2018
• 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: 73 YR