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

Model Number FR995-29

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

Patient Problems Atrial Fibrillation (1729); Infarction, Cerebral (1771); Death (1802)

Event Date 07/30/2020

Event Type  Death  

Manufacturer Narrative

Product analysis: the device remains implanted, therefore no product analysis can be performed.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.Replacement of the previous aortic bioprosthetic valve was reported in medwatch: 2025587-2020-02711.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that this full aortic root bioprosthetic valve was implanted as a part of an aortic root and ascending hemiarch replacement.The patient underwent the operation due to aortic root and ascending aorta aneurysms as well as degeneration of the previous bioprosthetic aortic valve.The surgeon reported that "this was a very challenging reoperative aortic root.There were significant mediastinal scarring that caused extensive difficulty with dissection".The patient tolerated the procedure without any significant intra-operative complications and was discharged to the intensive care unit in critical condition.It was reported that one day post operative the patient exhibited hemiparesis with a gaze deviation.The patient also experienced atrial fibrillation and respiratory failure requiring re-intubation on post op day seven.Two days later (nine days post implant), the patient became septic and exhibited signs of multi-system organ failure.Various medications were provided in attempt to address this.The patient then experienced an "acute neuro change with fixed pupils".The family elected to deescalate supportive measures and transitioned the patient to comfort care.The patient died 10 days post surgery.No issues with the bioprosthetic aortic root valve were reported.There is no evidence to indicate that the valve itself caused or contributed to these procedural related complications and the patient's ultimate death.No autopsy was performed.

• 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 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: 10806340
• MDR Text Key: 215249896
• Report Number: 2025587-2020-03471
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169008144
• UDI-Public: 00643169008144
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: FR995-29
• Device Catalogue Number: FR995-29
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• Date Device Manufactured: 11/04/2019
• 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
• Patient Age: 74 YR
• Patient Weight: 107