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

Model Number 310C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Corneal Pannus (1447); Abscess (1690); Endocarditis (1834); Sepsis (2067); Thrombus (2101); Tricuspid Regurgitation (2112); Complete Heart Block (2627)

Event Date 04/13/2015

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the customer, therefore no product analysis can be performed.Without return of the product, no definitive conclusions can be drawn regarding the clinical observation.Should additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that a non-medtronic permanent pacemaker was implanted for complete heart block following the implant of this 29mm bioprosthetic valve in the tricuspid position.Two months post implant, the patient had recurrent endocarditis and sepsis involving the valve, permanent pacemaker, and leads.Four months post implant, the valve, pacemaker, and pacing leads were replaced due to vegetation on the valve, pannus, thrombus, a periannular abscess, and regurgitation.The valve was replaced with a 27mm valve of the same model.No other adverse patient effects were reported.

Manufacturer Narrative

Conclusion: a review of the device history record (dhr) for this valve was performed, there was no issue identified regarding manufacturing and sterilization (raw materials, manufacturing time period, packaging and labelling, or sterilization load) that would have impacted this event.Cardiac dysrhythmias (i.E.Heart block) are known potential adverse events per mosaic instructions for use (ifu).These issues can be resolved with the implant of a permanent pacemaker.Without the return of the valve, root causes for the endocarditis and regurgitation were unable to be determined.However, based on the operative report, the patient had a history of intravenous (iv) drug abuse and a history of previous endocarditis; this clinical history indicates that the reoccurring endocarditis could be potentially due to a patient-related condition.

Manufacturer Narrative

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

• Brand Name: MOSAIC MITRAL BIOPROSTHETIC 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: 5160251
• MDR Text Key: 28687676
• Report Number: 2025587-2015-01091
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990064
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2019
• Device Model Number: 310C
• Device Catalogue Number: 310C29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/28/2014
• 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: 00033 YR