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

Model Number 995

Device Problem Insufficient Information (3190)

Patient Problems Stroke/CVA (1770); Low Cardiac Output (2501); Blood Loss (2597)

Event Date 07/30/2018

Event Type  Injury  

Manufacturer Narrative

Citation: goebel n et al.Combined david and frozen elephant trunk procedure in acute aortic dissection.Thorac cardiovasc surg.2019 aug;67(5):372-378.Doi: 10.1055/s-0038-1667179.Epub 2018 jul 30.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.Without return of the product no definitive conclusion can be made regarding the clinical observations.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a comparison of the valve-sparing surgical repair by reimplantation technique of david versus the conventional aortic root replacement with biological or mechanical prostheses in cases of acute debakey type i aortic dissections.All data were prospectively collected from a single center between october 2009 and december 2016.The overall study population included 48 patients (predominantly male; mean age 61 years), 15 patients from the aortic root replacement group were implanted with a medtronic freestyle bioprosthesis (no serial numbers provided).Among all patients in the aortic root replacement group, the 30-day mortality was 20% (4 patients).Multiple manufacturers were noted in the literature; based on the available information, medtronic product was not directly associated with the deaths.Among all patients in the aortic root replacement group, adverse events included: stroke, low cardiac output syndrome, and post-operative blood transfusion.Based on the available information, medtronic product may have been associated with the adverse events.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): 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: 9227141
• MDR Text Key: 176068601
• Report Number: 2025587-2019-03252
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• 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: 10/02/2019
• 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): Life Threatening
• Patient Age: 61 YR