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

Model Number FR995-25

Device Problem Material Rupture (1546)

Patient Problems Aortic Regurgitation (1716); Congestive Heart Failure (1783); Mitral Regurgitation (1964)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product remains implanted, therefore no product analysis can be performed.Conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Title: perceval s valve solution for degenerated freestyle root in the presence of chronic aortic dissection.Citation: the annals of thoracic surgery (2016) 101:2365¿7 (doi 10.1016/j.Athoracsur.2015.09.012) authors: antonio lio, antonio miceli, matteo ferrarini, and mattia glauber month and year of publish used for event date.No unique device identifier (serial) numbers were provided; without this information it cannot be determined whether this event has been previously reported.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 review that a (b)(6)-old female patient with a past medical history of an acute aortic dissection (aad), had been implanted with a 25 mm freestyle aortic root bioprosthesis.Eleven years after the implant the patient experienced a cuspal rupture, mitral regurgitation and severe aortic regurgitation that led to acute heart failure.A non medtronic aortic bioprosthetic valve was implanted valve-in-valve.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 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: 5729013
• MDR Text Key: 47513132
• Report Number: 2025587-2016-00890
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2016
• 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: 05/31/2016
• 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: 72 YR