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 Problem Endocarditis (1834)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis.Without the receipt of the product, no definitive conclusion can be made regarding the clinical observation.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 that four weeks post implant of this bioprosthetic mitral valve, this patient presented with evidence of thrombophlebitis from a previous intravenous (iv) site, was having significant shortness of breath, and appeared to be sick and septic.The patient was admitted to the emergency department with rapid atrial fibrillation and cardiac decompensation.Echocardiogram showed evidence of severe mitral regurgitation with a rocking mitral valve.Acute renal failure followed.Medication, in the form of multiple pressors, milrinone, and norepinephrine, was administered and an intraaortic balloon pump was placed.After the mitral valve was exposed during this replacement procedure, there was significant amounts of thrombus and necrosis of the posterior mitral annulus.The tissue was debrided, and a replacement heart valve was placed.The physician reported that a sample of the valve sent to the pathology lab did not grow any organism.The physician also stated that there was no valvular involvement in this endocarditis.No other adverse patient effects were reported.

Manufacturer Narrative

Analysis: the organism of the endocarditis is unknown.The physician reported that a sample of the valve sent to the pathology lab did not grow any organism.The physician also stated that there was no valvular involvement in this endocarditis.The medtronic tissue bioprosthetic heart valve product manufacturing processes involves a series of tissue treatments to fix the tissue and to reduce the bioburden level prior the terminal sterilization step to yield a sterile product.The terminal sterilization process is validated using bacillus atrophaeus.To minimize the risk further, finished assembled valve products are packaged with sterilized components in jars and lids.Validation studies of the manufacturing and sterilization process demonstrated that a sterility assurance level of 10-6 or better will be met against mycobacteria and bacillus species.Finished products are only released with acceptable bioburden results.Additionally, acceptable sterility testing result is a requirement for finished product release.Additionally, the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Conclusion: it was unlikely that the endocarditis originally came from the device and/or manufacturing valve process.The reported regurgitation possibly was due to the endocarditis.

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 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 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: 6160027
• MDR Text Key: 62114025
• Report Number: 2025587-2016-01981
• 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,Followup
• Report Date: 01/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/19/2021
• Device Model Number: 310C
• Device Catalogue Number: 310C29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/09/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/25/2017
• Supplement Dates FDA Received: 12/28/2016; 01/26/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/20/2016
• 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: 74 YR