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

Model Number 995

Device Problems Calcified (1077); Gradient Increase (1270)

Patient Problems Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Congestive Heart Failure (1783); Cardiac Enzyme Elevation (1838); Left Ventricular Dysfunction (1947)

Event Date 03/28/2017

Event Type  Injury  

Manufacturer Narrative

Citation: karimi a et al.High-risk trans-catheter aortic valve replacement in a failed freestyle valve with low coronary height cardiol ther.2017 mar 28.Doi: 10.1007/s40119-017-0088-4.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 of a (b)(6) year-old male patient with a bicuspid aortic valve who underwent implant of a medtronic freestyle stentless aortic root bioprosthesis (serial number not provided).Ten years following the valve implant, the patient presented with elevated cardiac enzymes and decompensated heart failure.Transthoracic echocardiogram (tte) revealed severe aortic insufficiency with an elevated mean gradient of 26mmhg and left ventricular dysfunction.An elongated mobile density was noted on the valve thought to be either a healed vegetation, as blood cultures were negative, or degenerative valve leaflet prolapse.Computed tomography (ct) scan showed the bioprosthetic to be calcified.Subsequently, a non-medtronic transcatheter bioprosthetic valve was implanted valve-in-valve.During the implant, it was noted that the pigtail was used as a marker due to the freestyle root not possessing a radiopaque ring marker or visible posts.Following the implant, the final root angiogram showed the aortic insufficiency was resolved.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 the adverse events, and provided the valve size (27mm) without serial numbers, and the patient's weight ((b)(6)).

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: 6530604
• MDR Text Key: 73963577
• Report Number: 2025587-2017-00713
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2017
• 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?: Yes
• Date Manufacturer Received: 05/23/2017
• 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): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 79