MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION FREESTYLE AORTIC ROOT BIOPROSTHESIS; HEART-VALVE, NON-ALLOGRAFT TISSUE

Model Number 995

Device Problem Torn Material (3024)

Patient Problems Cardiomyopathy (1764); Death (1802); Hemorrhage/Bleeding (1888); Liver Damage/Dysfunction (1954); Renal Failure (2041); Thrombus (2101); Respiratory Acidosis (2482); Respiratory Failure (2484); Complete Heart Block (2627); Multiple Organ Failure (3261)

Event Date 01/14/2015

Event Type  Death  

Manufacturer Narrative

Additional information was received that this valve was not retrieved during the autopsy and will not be returned for analysis.

Manufacturer Narrative

Additional information was received that the patient's weight was (b)(6).

Event Description

Medtronic received information that following the implant of this bioprosthetic valve, the patient was noted with mediastinal bleeding in the left main coronary artery (lmca) due to a perforation in the left ventricular outflow tract (lvot).The physician attempted to repair the perforation without success and put the patient back on bypass for removal of the aortic bioprosthetic valve and replacement with an aortic root bioprosthetic valve.During the intervention period the patient was noted to have ischemic cardiomyopathy with right and left ventricular dysfunction.Thrombus was removed from the lmca and only a small amount of bleeding was noted around the cannulation site.The patient¿s hemodynamics were deteriorating and the patient was put on bi-ventricular assist device (bi-vad) and intra-aortic balloon pump (iabp).The patient was also noted to have cardiogenic shock, acute kidney injury, liver shock and respiratory failure.Post-operative day 1 the patient developed complete heart block, subsequently a permanent pacemaker was implanted.Post-operative day 5 the patient¿s echo showed significant global hypokinesis.Post-operative day 7 the patient developed severe metabolic acidosis and multi organ failure.Subsequently the patient passed away.Cause of death was noted to be multi-organ failure.It was noted by the physician that since the right coronary artery (rca) could not be re-implanted with the root replacement due to chronic rca occlusion, that, that may have contributed to the right ventricular dysfunction.

Manufacturer Narrative

The first valve noted in the event description will be sent in on a separate medwatch form.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.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.(b)(4).

Manufacturer Narrative

Conclusion: based on the received information, there was no allegation that the death was related to the valve or its function, but rather it was related to the procedural conditions and/or patient anatomy.Medtronic will continue to monitor field performance for similar events should they occur.

Manufacturer Narrative

No eval explain code.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: FREESTYLE AORTIC ROOT BIOPROSTHESIS
• 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: 4507096
• MDR Text Key: 12839385
• Report Number: 2025587-2015-00193
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P970031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,health professional,stu
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/18/2015

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: 09/09/2019
• Device Model Number: 995
• Device Catalogue Number: FR995-23
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 02/11/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 05/18/2015
• Supplement Dates FDA Received: 02/11/2015; 03/10/2015; 06/08/2015; 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2014
• 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): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 00076 YR
• Patient Weight: 99