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

Model Number 40023

Device Problems Incomplete Coaptation (2507); Insufficient Information (3190)

Patient Problem Aortic Valve Insufficiency/ Regurgitation (4450)

Event Date 01/11/2023

Event Type  Injury  

Event Description

Medtronic received information that the same day post implant of this 23mm aortic bioprosthetic valve, it was explanted and replaced with a non-medtronic mechanical valve.The reason for the replacement was reported as post implant transesophageal echocardiogram performed noted what looked like severe regurgitation between the right and the non-coronary leaflets.It was reported that the surgeon is unsure what caused the event, if this was a valve related issue or something which occurred during the valve implant surgery.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve appeared discolored showing evidence of blood contact.The mid-sections of all leaflets appeared excised.All leaflets were stiff yet flexible.The free margins of all leaflets approaching all commissures appeared discolored and dry.Commissures 1-2, and 2-3 appeared intact.An indentation was noted on leaflet 3 approaching commissure 3-1 possibly from instruments used during explant.Post 1 and 3 appeared intact.Minor deflection noted on post 2.Small needle holes along the sewing cuff show placement of implantation sutures; remnant green multifilament suture remained attached to the sewing cuff below leaflet 2.The sewing cuff adjacent to l2 appeared inverted.Multiple tears were observed along the stent cloth cover exposing the stent.Conclusion: the investigation is in progress.A supplemental report will be submitted after completion of the investigation.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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 additional information which stated that the severe regurgitation present appeared to be due to the leaflets of the bioprosthetic valve not coapting.Upon examination, there appeared to be noncoaptation of the leaflets of the valve placed along the right and non-coronary sinus.It was reported that the right coronary sinus leaflet was observed to be somewhat folded.It was mentioned that there was no evidence of any sutures causing damage to the leaflet.It was noted that the annulus was sized to 23mm.It was also noted the aortic valve area was measured to be approximately 0.6 to 0.7 sq cm.It was indicated that after removal of the bioprosthetic valve, the annulus was sized again and a 21mm non-medtronic mechanical valve was subsequently implanted.Pathology results revealed dense fibroconnective tissue compatible with a porcine valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

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 analysis and the echo review, it appears that the likely cause of the aortic regurgitation was due to external compression of the bioprosthesis.As part of the investigation, a radiographic image of the valve was taken to check if there was evidence of fracture of the stent that could have caused compression of the valve.There was no evidence of fractures noted on the stent.The underlying reason for the compression of the valve could not be determined.H6: updated medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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: 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: 16326876
• MDR Text Key: 309076976
• Report Number: 2025587-2023-00456
• Device Sequence Number: 1
• Product Code: LWR
• UDI-Device Identifier: 00643169983199
• UDI-Public: 00643169983199
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 40023
• Device Catalogue Number: 40023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 98 KG