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

Model Number 995

Device Problem Structural Problem (2506)

Patient Problems Stroke/CVA (1770); Endocarditis (1834); Blood Loss (2597)

Event Date 05/12/2016

Event Type  Injury  

Manufacturer Narrative

Citation: yang, b.Md, phd et al.Sixteen-year experience of david and bentall procedures in acute type a aortic dissection.Annals of thoracic surgery.(2018).Mar;105(3):779-784; doi 10.1016/j.Athoracsur.2017.09.029 earliest date of e-publish/publish used for event.No unique device identifier (serial/lot) numbers were provided; without this information, it cannot be determined whether this event has been previously reported.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature review regarding 16 year outcomes after a david or bentall procedure to treat a type a aortic dissection.All data were collected from a single center between 2001 and 2017.The study population included 135 patients, some which were implanted with a freestyle aortic root bioprosthesis during a bentall procedure.The remaining patients were implanted with a non medtronic device.Serial numbers were not provided.The bentall study population was predominantly male; mean age 61 years.Among all patients, none of the deaths were attributed to a medtronic product.Among all patients adverse events included: cerebral vascular accident (cva), blood loss, endocarditis, atrial fibrillation (afib), myocardial infarction (mi), complete heart block (chb), structural deterioration with subsequent aortic insufficiency and reoperation.Based on the available information, these events may have been attributed to a medtronic product.However as multiple manufacturers were noted in the literature, a direct correlation could not be made between the observed adverse events and the medtronic product.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Pma/510(k) number was inadvertently omitted on the initial report and has been added to this report.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: 7427357
• MDR Text Key: 105366024
• Report Number: 2025587-2018-00857
• 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
• Report Date: 04/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• 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: 04/12/2018
• 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: 61 YR