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

Model Number 995CS19

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problems Non specific EKG/ECG Changes (1817); Hemorrhage, Cerebral (1889); Renal Failure (2041); Blood Loss (2597)

Event Date 10/17/2015

Event Type  Injury  

Manufacturer Narrative

Citation: zain khalpey, md journal: ann thorac surg 2016: 101(2):650-7 10.1016/j.Athoracsur.2015.07.081 article title: nineteen-millimeter bioprosthetic aortic valves are safe and effective for elderly patients with aortic stenosis earliest date of publish used for event date.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 the use of 19-mm aortic valves in elderly patients with a small aortic root.All data were collected from a single center between january 2002 and december 2011.The study population included 257 patients predominantly female, mean age 77 years, 12 of which were implanted with medtronic freestyle/mosaic (serial numbers not provided).Among all patients adverse events included: patient prosthesis mismatch, reoperation for bleeding, stroke, renal failure, atrial fibrillation (afib), permanent pacemaker implant.Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.No additional adverse patient effects or product performance issues were reported.

• Brand Name: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): HEART VALVES SANTA ANA; 1851 e deere ave; santa ana CA 92705
• Manufacturer (Section G): HEART VALVES SANTA ANA; 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: 6688324
• MDR Text Key: 79118096
• Report Number: 2025587-2017-01102
• 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
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 995CS19
• Device Catalogue Number: 995CS19
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2017
• 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: 77 YR