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

Model Number CF99519025

Device Problem Obstruction of Flow (2423)

Patient Problems Thrombosis (2100); No Information (3190)

Event Date 04/01/2008

Event Type  Injury  

Manufacturer Narrative

The article contents did not provide information as to which devices were associated with the reported adverse events, no patient de mographics were provided, and no details were provided for any of the three medtronic models (i.E., serial numbers, number of devices implanted, etc.).Without device serial numbers, a review of device history records could not be performed.Based on the limited i nformation received, a root cause of the adverse events could not be determined.

Event Description

Medtronic received information from a journal article that devices from this model family were included in a review of previously published literature regarding the use of valved conduits in right ventricular outflow tract (rvot) reconstruction.Observations associated with freestyle porcine aortic roots included surgical reoperation for conduit obstruction and thrombosis.The article did not include enough detailed complaint or patient information to be able to determine the number of observations of each complaint or the average patient demographics.

Manufacturer Narrative

Without device- or patient-identifying information, a search of medtronic¿s database for previously-submitted complaint reports could not be conducted.(b)(4).Right ventricular outflow tract reconstruction: valved conduit of choice and clinical outcomes authors: shi-min yuana, david mishalyb, amihay shinfelda and ehud raanania.Department of cardiac and thoracic surgery, the chaim sheba medical center, tel hashomer, israel.Journal of cardiovascular medicine april 2008, vol 9 no 4, 9:327¿337.Doi: 10.2459/jcm.0b013e32821626ce.

Manufacturer Narrative

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

• 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 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: 4237610
• MDR Text Key: 16696563
• Report Number: 2025587-2014-00856
• 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,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF99519025
• Device Catalogue Number: CF99519025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2014
• 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): Hospitalization; Required Intervention