MAUDE Adverse Event Report: SORIN GROUP USA, INC. MITROFLOW; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number LXA23

Device Problems Occlusion Within Device (1423); Appropriate Term/Code Not Available (3191)

Patient Problems Aortic Regurgitation (1716); Cardiomyopathy (1764)

Event Date 11/18/2014

Event Type  Injury  

Event Description

The patient is a pediatric female with a history of unbalanced chromosome 2 and 3 translocation, developmental delay, seizures, failure to thrive and gastrostomy tube dependence.Her initial cardiac anatomy: large membranous ventricular septal defect (vsd), dysplastic aortic and pulmonary valves with obstruction, and asymmetric septal hypertrophy consistent with hypertrophic cardiomyopathy.She underwent vsd closure, infundibular muscle bundle resection, transannular right ventricular outflow tract patch, and sub-aortic myomectomy at (b)(6) months of age.She had an aortic valvuloplasty and repeat sub-aortic myomectomy, as well as pulmonary valve insertion (23mm mitroflow valve) for severe pulmonary regurgitation at approximately (b)(6) years of age, followed by a redo aortic valvuloplasty for regurgitation several days later.At approximately (b)(6) years of age she had augmentation of the aortic annulus and aortic valve replacement (19mm mitroflow valve) for severe aortic regurgitation.She has been followed very closely and noted to have stable, low aortic valve gradients through 2 years following implant, and then a more rapid rise over the last 6 months.The valve was electively explanted 2 years post implant with moderate obstruction in the face of underlying hypertrophic cardiomyopathy.A mitroflow valve that was placed in the pulmonary position from a prior surgery was also explanted at the time the aortic valve was explanted.

• Brand Name: MITROFLOW
• Type of Device: HEART-VALVE, NON-ALLOGRAFT TISSUE
• Manufacturer (Section D): SORIN GROUP USA, INC.; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 4357148
• MDR Text Key: 5119269
• Report Number: 4357148
• Device Sequence Number: 2
• Product Code: LWR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/19/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: LXA23
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/19/2014
• Device Age: 4 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/23/2014
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 10 YR
• Patient Weight: 21