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

Model Number 995

Device Problem Gradient Increase (1270)

Patient Problems Wound Dehiscence (1154); Non specific EKG/ECG Changes (1817); Endocarditis (1834); Hemorrhage, Cerebral (1889); Hemostasis (1895); Unspecified Infection (1930); Myocardial Infarction (1969); Pulmonary Regurgitation (2023); Pulmonary Valve Stenosis (2024); Renal Failure (2041); Respiratory Failure (2484); Complete Heart Block (2627); Thromboembolism (2654)

Event Date 02/17/2016

Event Type  Injury  

Manufacturer Narrative

Citation: cheul lee article title: outcomes of redo pulmonary valve replacement for bioprosthetic pulmonary valve failure in 61 patients with congenital heart disease european journal of cardio-thoracic surgery 2016: 50(3):470-5; 10.1093/ejcts/ezw037 earliest date of publish used for event date.No unique device identifier serial numbers were provided; without this information it could not be determined whether these observations have been previously reported.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding the outcomes of redo pulmonary valve replacement (pvr) for bioprosthetic pulmonary valve failure in patients with congenital heart disease all data were collected from a single center between november 1999 and june 2013.The study population included 61 patients predominantly male; mean age at initial pvr was 7.0 years and the median age at redo pvr was 13.5 years, 17 of the 61 were implanted with medtronic freestyle and 14 were implanted with a medtronic hancock ii (serial numbers not provided).Among all patients, adverse events included: redo operation due to pulmonary stenosis, pulmonary regurgitation and infective endocarditis resulting in high gradients.Also reported were stroke, myocardial infarction, renal failure, respiratory complications, sternotomy wound problems (infection and superficial dehiscence), bleeding and postoperative arrhythmia's (1 permanent pacemaker for complete heart block (chb).Multiple manufacturers were noted in the literature; based on the available information a direct correlation could not be made between the observed adverse events and medtronic product.

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 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: 6132774
• MDR Text Key: 61084309
• Report Number: 2025587-2016-01873
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 11/17/2016
• 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: 13 YR
• Patient Weight: 47