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

Model Number 995

Device Problems Calcified (1077); Perivalvular Leak (1457); Material Rupture (1546); Inadequacy of Device Shape and/or Size (1583)

Patient Problems Aortic Regurgitation (1716); Atrial Fibrillation (1729); Calcium Deposits/Calcification (1758); Endocarditis (1834); Renal Failure (2041); Cusp Tear (2656)

Event Date 02/17/2014

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Event Description

Medtronic received information via literature review that a study was performed to evaluate whether the implantation technique of the freestyle stentless bioprosthesis (fsb) (serial numbers not provided) had an impact on late reoperation for structural valve deterioration (svd).The study population included 531 patients predominantly male with a mean age of 68 years.Among all patients, 281 deaths occurred over a 20 year period, which included: chronic obstructive pulmonary disease, reoperation for all causes, and older age.Of these deaths, none were directly attributed to the valve or its function.Among all patients, all reported adverse events included: atrial fibrillation (afib), bleeding, renal failure, stroke, mediastinitis, patient-prosthesis mismatch, endocarditis, leaflet tear, calcification, aortic insufficiency, paravalvular leak (pvl), reoperation for structural valve deterioration (svd) and non-svd causes (median time 4.2-12 years depending on implant technique).No additional adverse patient effects 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 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: 5332804
• MDR Text Key: 34614092
• Report Number: 2025587-2015-01416
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• 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: 12/14/2015
• 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