MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505DM18

Device Problems Inadequacy of Device Shape and/or Size (1583); Insufficient Information (3190)

Patient Problems Mitral Valve Stenosis (1965); Insufficient Information (4580)

Event Date 12/28/2021

Event Type  Injury  

Manufacturer Narrative

Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that 9 years and 1 month post implant of this 18mm mitral mechanical valve, it was explanted and replaced with a 20mm valve of the same model.The reason for the replacement was not reported.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that the valve leaflets appeared intact with no evidence of damage such as cracks and/or surface anomalies.Both leaflets were received in the closed position.A blue actuator was used to test leaflet movement; one leaflet partially opened; second leaflet could not be opened.The pannus overgrowth around the orifice appeared to restricted leaflet mobility.Thick, off-white pannus overgrowth covered one of the hinge mechanisms.Glistening off-white pannus lines the sewing cuff on the inflow and outflow.Pannus overgrowth extends up to 7mm into the leaflets of the outflow showing evidence of a reduced orifice area.The pannus overgrowth was removed from the orifice and hinge mechanisms.After removal, both hinge mechanisms appeared intact with no evidence of damage.Using a blue actuator to test leaflet movement, the leaflets were fully mobile.The orifice appeared intact with no evidence of damage.Due to the pannus overgrowth, the carbon subassembly cannot be rotated in the sewing ring.Radiography did not reveal calcification on the valve.Conclusions: 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, it is evident that the pannus overgrowth contributed to the reported stenosis.Additionally, the patient's growth may have contributed to the event.H3: device evaluated updated h6: updated the codes 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

Product analysis: the product has been returned and analysis is in progress.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 the reason for replacement was stenosis.It was reported that the patient's growth may have contributed to the event.No additional adverse patient effects were reported.

• Brand Name: OPEN PIVOT AP360 HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13357977
• MDR Text Key: 284451547
• Report Number: 3008592544-2022-00002
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DM18
• Device Catalogue Number: 505DM18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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): Hospitalization; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Male
• Patient Weight: 40 KG