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

Model Number 40027

Device Problems Inadequacy of Device Shape and/or Size (1583); Patient Device Interaction Problem (4001)

Patient Problem Rupture (2208)

Event Date 03/04/2024

Event Type  Injury  

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that during the implant of this 27mm aortic bioprosthetic valve, it was reported that after sizing, an attempt was made to implant the valve, but "it could not be dropped properly." it was stated that a decision was made to cut the apex of the valve and the valves corresponding 27mm sizer would pass.It was noted that a non-medtronic 27mm sizer passed with room to spare.The valve ring was not torn and there was no damage.It was also reported that the preoperative ejection fraction was 34%.It was noted that the anastomotic position of the right coronary artery was not good and the flow was poor, so the anastomosis was changed.During the attempt at implantation of this 25mm valve, the aortic valve annulus ruptured and coronary blood flow could notbe confirmed, so an urgent bypass to the right coronary artery was performed and the valve was replaced with a 25mm valve of the same model.It was also reported that when the chest was re-opened due to bleeding, the physician may have restarted the chest too late.It was indicated that it was consequently thought that the 27mm may have been oversized.Low output syndrome (los) was observed and intra-aortic balloon pump therapy (iabp) was introduced.The patient is reported to be brain dead post-operatively.It was mentioned that there were various events that resulted in brain death, however, it is unknown if it was caused by this event or not.It was also reported that the physician does not believe that the potential oversizing of the valve was the direct cause of the patients death.It was noted that a ascending aorta replacement was also performed during this procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

Correction - b5: the sentence "during the attempt at implantation of this 25mm valve, the aortic valve annulus ruptured and coronary blood flow could not be confirmed, so an urgent bypass to the right coronary artery was performed and the valve was replaced with a 25mm valve of the same model" in the event description has been corrected to "during the attempt at implantation of this 27mm valve, the aortic valve annulus ruptured and coronary blood flow could not be confirmed, so an urgent bypass to the right coronary artery was performed and the valve was replaced with a 25mm valve of the same model." medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Medtronic received information that during the implant of this 27mm aortic bioprosthetic valve, it was reported that after sizing, an attempt was made to implant the valve, but "it could not be dropped properly." it was stated that a decision was made to cut the apex of the valve and the valves corresponding 27mm sizer would pass.It was noted that a non-medtronic 27mm sizer passed with room to spare.The valve ring was not torn and there was no damage.It was also reported that the preoperative ejection fraction was 34%.It was noted that the anastomotic position of the right coronary artery was not good and the flow was poor, so the anastomosis was changed.During the attempt at implantation of this 27mm valve, the aortic valve annulus ruptured and coronary blood flow could notbe confirmed, so an urgent bypass to the right coronary artery was performed and the valve was replaced with a 25mm valve of the same model.It was also reported that when the chest was re-opened due to bleeding, the physician may have restarted the chest too late.It was indicated that it was consequently thought that the 27mm may have been oversized.Low output syndrome (los) was observed and intra-aortic balloon pump therapy (iabp) was introduced.The patient is reported to be brain dead post-operatively.It was mentioned that there were various events that resulted in brain death, however, it is unknown if it was caused by this event or not.It was also reported that the physician does not believe that the potential oversizing of the valve was the direct cause of the patients death.It was noted that a ascending aorta replacement was also performed during this procedure.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

Additional information was received that reported the valve was sized using the barrel end of the sizer, but the replica end was not used.It was also reported that the valve was not found to be between two different sizes.It was preference of the physician to upsize the valve for a larger effective orifice area (eoa).The body surface area (bsa) chart was not used.Pledgets were used during the implant, and the valve was not resized following pledget placement.No additional adverse patient effects were reported.

• Brand Name: AVALUS AORTIC TISSUE 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 19038041
• MDR Text Key: 339320610
• Report Number: 2025587-2024-02085
• Device Sequence Number: 1
• Product Code: LWR
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P170006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/16/2024

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 Model Number: 40027
• Device Catalogue Number: 40027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 04/03/2024
• Supplement Dates Manufacturer Received: 04/12/2024; 04/11/2024
• Supplement Dates FDA Received: 04/12/2024; 04/16/2024
• Date Device Manufactured: 12/05/2022
• 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