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

Model Number 310C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems High Blood Pressure/ Hypertension (1908); Mitral Regurgitation (1964); Rupture (2208)

Event Date 01/17/2017

Event Type  Death  

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.(b)(4).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 from this patient's physician that this patient presented with severe pulmonary hypertension, and significant pulmonary pink froth was seen coming from the patient's endotracheal (et) tube.The physician noted that this was a high-risk procedure.A pre-operative transesophageal echocardiogram (tee) showed severe mitral regurgitation.Intra-operatively findings included "a flail leaflet of the mitral valve with a full ruptured large papillary muscle extending past, through, and into the aortic valve." upon visualizing the cardiac anatomy in situ, the physician also noted "significant friable tissue.Of the atrium, superior, and inferior vena cava." the ruptured papillary muscle was removed, the chordae tendinae were removed, and the native mitral valve was removed.This 25mm bioprosthetic mitral valve was implanted.However, following implant and inspection of this valve, the device was found to be inadequate.This device was removed and a 27 mm bioprosthetic valve was implanted.An aortic valve replacement was then undertaken.The patient was weaned off cardiopulmonary bypass and significant frothy red fluid was again noted in the patient's et tube.The patient had multiple episodes of ventricular tachycardia and expired.

Manufacturer Narrative

Medtronic received additional information from this patient's physician that an autopsy was not performed the patient's cause of death was: cardiogenic shock, status post acute myocardial infarction (mi), coronary artery disease, severe mitral regurgitation, aortic valve insufficiency, multi system failure, pulmonary edema, respiratory failure, and renal failure.No medtronic product was implicated in the cause of death."outcome attributed to adverse event" changed to "intervention required".

Manufacturer Narrative

Conclusion: 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.Based on the information available, it was suggested that reported occurrence could be potentially related to a sizing issue.Improper sizing is a known failure mode.In addition, the cause of death was ascertained to be unrelated to the valve or its function.There was no intrinsic evidence to suggest a root cause related to manufacturing.

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 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: 6327756
• MDR Text Key: 67317288
• Report Number: 2025587-2017-00235
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169594838
• UDI-Public: 00643169594838
• 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: 03/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/04/2021
• Device Model Number: 310C
• Device Catalogue Number: 310C25
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/05/2016
• 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): Death; Required Intervention
• Patient Age: 64 YR