MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MOSAIC PORCINE HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 31027

Device Problem Gradient Increase (1270)

Patient Problem Mitral Valve Stenosis (1965)

Event Date 02/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: simultaneous double valve-in-valve tavi procedure for failed bioprostheses citation: ann thorac surg 2015;99:722¿4 authors: markus schlomicher, md, peter lukas haldenwang, md, vadim moustafine, md, matthias bechtel, md, phd, and justus thomas strauch, md, phd month and year of publish used for event date in b3.No unique device identifier (serial/lot) numbers were provided; without this information it cannot be determined whether this event has been previously reported.

Event Description

Medtronic received information via literature review that a case study was performed after non-medtronic transcatheter valves were implanted, valve-in-valve, into a medtronic surgical aortic bioprosthetic valve (25mm, serial numbers not provided) and a medtronic surgical bioprosthetic mitral valve (27-mm, serial numbers not provided).The patient was a (b)(6) year old female with a past medical history of chronic atrial fibrillation, moderate left ventricular dysfunction and type two diabetes.The bioprosthetic valves had been implanted for four years, and both demonstrated structural deterioration.The aortic valve was reported to have moderate aortic insufficiency.The mitral valve was reported to be stenotic with increased mitral gradients.The reason for the early deterioration was not clear to the author.The non-medtronic transcatheter valves were successfully implanted.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: MOSAIC PORCINE HEART VALVE
• 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: 5300158
• MDR Text Key: 33585265
• Report Number: 2025587-2015-01323
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990064
• 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: 11/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 31027
• Device Catalogue Number: 31027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• 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: 00078 YR