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 Low Cardiac Output (2501); Blood Loss (2597); Pseudoaneurysm (2605)

Event Date 10/26/2012

Event Type  Injury  

Manufacturer Narrative

Citation: miceli a et al.Root replacement with stentless freestyle bioprostheses for active endocarditis: a single centre experience.Interactive cardiovascular and thoracic surgery.2013; 16:27-30.Doi: 10.1093/icvts/ivs438.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 the postoperative outcomes of stentless bioprosthetic valves in patients undergoing aortic root replacement following valvular endocarditis.All data were collected from a single center between february 2000 and june 2010.The study population included 180 patients (predominantly female, mean age 66.7 years, mean weight 73.2 kg), 18 of which were implanted with medtronic freestyle bioprosthetic aortic root replacements (no serial numbers provided).Among all medtronic freestyle patients, 2 deaths occurred in-hospital because of septic shock.Based on the available information medtronic product was not directly associated with the deaths.Among all medtronic freestyle patients, adverse events included: major bleeding, pseudoaneurysm, and low cardiac output.One patient required reintervention for major bleeding.Two patients required reintervention because of a pseudoaneurysm at 1 month and 23 months post implant of the freestyle valve.The authors attributed the pseudoaneurysms to native tissue degeneration and excessive use of gelatine resorcinol formaldehyde glue, respectively.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: 9825808
• MDR Text Key: 188628973
• Report Number: 2025587-2020-00763
• 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
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2020
• 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: 02/27/2020
• 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: 67 YR
• Patient Weight: 73