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

Model Number 995

Device Problems Perivalvular Leak (1457); Inadequacy of Device Shape and/or Size (1583); Structural Problem (2506); Patient-Device Incompatibility (2682)

Patient Problems Aortic Regurgitation (1716); Aortic Valve Stenosis (1717); Calcium Deposits/Calcification (1758); Fibrosis (3167)

Event Date 03/23/2006

Event Type  Injury  

Manufacturer Narrative

To date, no additional information has been received from an author of the article.Based on the limited information received, a root cause of the complaints cannot be determined.

Manufacturer Narrative

Product analysis: literature article.No product available for analysis.Conclusion: the device history record (dhr) could not be reviewed as no serial numbers were provided.Per the author, the study determined the freestyle stentless bioprosthesis showed freedom from structural valve deterioration was 95.8% at ten years.(b)(4).

Event Description

Medtronic received information from a journal article entitled structural deterioration of the freestyle aortic valve: mode of presentation and mechanisms, featured in the journal of thoracic and cardiovascular surgery (doi:10.1016/j.Jtcvs.2006.03.056).The article evaluated the mechanisms and clinical presentation of structural valve dysfunction (svd) in the freestyle stentless bioprosthesis.The study included 608 patients who received a freestyle valve, 475 implanted via subcoronary and 133 implanted via root replacement, between january 1993 and august 2004.Twenty-seven patients required reoperation or explant, twelve of whom showed evidence of structural valve dysfunction (svd) diagnosis.Four of the explants were due to technical issues.An additional eleven explants were due to late technical issues.Of the eleven technical issues, three explants were due to severe mismatch, two explants were due to endocarditis, three explants were due to paravalvular leak, two explants were due to partial dehiscence of root replacement, and one explant was due to central regurgitation.Per the author, the study determined the freestyle stentless bioprosthesis showed freedom from structural valve deterioration was 95.8% at ten years.

Manufacturer Narrative

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 STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 4226911
• MDR Text Key: 12598029
• Report Number: 2025587-2014-00839
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Literature,Health Professional,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 11/05/2014
• Supplement Dates Manufacturer Received: Not provided; 11/24/2014
• Supplement Dates FDA Received: 11/27/2014; 09/15/2017
• 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: 00068 YR