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

Model Number 305C27

Device Problems Gradient Increase (1270); Malposition of Device (2616)

Patient Problems Dyspnea (1816); Fatigue (1849); Weakness (2145)

Event Date 09/01/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Title: prosthetic pulmonary valve stenosis: a different way to solve the problem citation: the annals of thoracic surgery (doi 10.1016/j.Athoracsur.2014.11.065).Authors: thomas schroeter, md, philipp lurz, md, phd, philipp kiefer, md, mahmoud wehbe, md, and ingo dahnert, md, phd earliest date of e-publish/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 (b)(6) year-old male patient with a history of a ross procedure due to aortic stenosis underwent the implant of a 27 mm mosaic bioprosthesis in the pulmonary position and a 25 mm mosaic bioprosthesis in the aortic position.Two years later, the patient presented with dyspnea, weakness and fatigue.It was noted that the pulmonary bioprosthesis had been mal-rotated, resulting in increased gradients and stenosis.Multiple stents were placed to extend across the right ventricular outflow tract (rvot), the pulmonary bioprosthesis and into the pulmonary artery.A balloon aortic valvuloplasty (bav) was then performed to rotate the axis of the valve.A medtronic transcatheter bioprosthetic pulmonary valve was successfully implanted with no resulting regurgitation or stenosis.No other adverse patient effects were reported.No serial numbers were provided.

Manufacturer Narrative

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.

• Brand Name: MOSAIC
• 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: 5973406
• MDR Text Key: 55473287
• Report Number: 2025587-2016-01514
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 305C27
• Device Catalogue Number: 305C27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2016
• 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: 84 YR