MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC AP; HEART-VALVE, MECHANICAL

Model Number 501DA24

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 02/25/2020

Event Type  malfunction  

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 after seating this mitral mechanical valve into the annulus and removing the holder, one leaflet of the mechanical valve became detached and fell into the left ventricle.The leaflet was successfully retrieved and the valve was removed.A non-medtronic mechanical valve was implanted.No adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information was received that the valve was not fully sutured in when the leaflet detached.Additionally, it was reported that the leaflet motion had not yet been tested nor had the valve been rotated within the annulus when the leaflet detached.No adverse patient effects were reported.A1: patient identifier added a4: patient weight added b1/b2: adverse event/product problem status corrected."intervention required" was un-checked.There were no reported adverse events associated with this event/product problem.D10 and h3: device evaluation status updated h6: coding updated product analysis: the device has been returned to medtronic, and device analysis will be completed.Upon completion, a supplemental medwatch will be submitted.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: upon receipt at medtronic's quality laboratory, visual examination revealed that one leaflet remained attached to the main valve assembly with the other leaflet detached.Marginal damage to the sewing cuff exposed part of the stiffening ring.Both the attached and detached leaflet appeared intact with no evidence of damage such as cracks or surface anomalies.Using an actuator, the attached leaflet appeared to move without difficulty.Both inflow and outflow valve hinge mechanisms appeared intact.The inflow and outflow orifices appeared intact with no evidence of damage.Conclusions: the investigation is in progress, and a supplemental report will be submitted upon its completion.H3: device evaluated? updated h6: coding 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.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

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.The valve was sent to the manufacturing site for further analysis.A secondary visual analysis showed that there is potential evidence that the carbon orifice in the pivot area was damaged.However, there is no conclusive evidence that the left leaflet was forcibly removed from the orifice.To determine if any manufacturing-related reason could have contributed to the leaflet falling out, several component critical dimensions (leaflets and orifice) which should prevent the leaflet from falling out were re-measured and found to be within specification.In addition, the critical valve assembly dimension, crown-to-notch, part of the design as to secure the leaflets and prevent the leaflets fell out was re-measured.The results are within design specification.Therefore, it confirmed that the device met all applicable manufacturing specifications.The design of the stiffening ring inserted on the outside of the orifice is intended to maintain the circularity of the orifice, thereby keeping the leaflets in place inside the orifice.As a result, due to the design of the stiffening ring, it is not anticipated that the leaflet will fall out.After a thorough review of the information received from this complaint, subject matter expert evaluation, device history record review, as well as the existing device design, medtronic could not identify the cause for the leaflet falling out.Based on reported complaints, there is a very low occurrence rate of a leaflet falling out during implant.These user/implant techniques could be important contributing factors for leaflet detachment during implant: (1) using other instruments for valve rotation, (2) applying excessive force while rotating the valve leaflets, (3) rotating the valve using the leaflet rather than using the rotator, (4) handling/pulling the valve by grasping the leaflet, or (5) holding and compressing (pinching) the valve by contacting the ¿non-pivot areas¿ of the valve.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: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 9849063
• MDR Text Key: 185598149
• Report Number: 3008592544-2020-00023
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2024
• Device Model Number: 501DA24
• Device Catalogue Number: 501DA24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2020
• Initial Date Manufacturer Received: 02/25/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 05/15/2020; 06/12/2020; 08/24/2020
• Supplement Dates FDA Received: 06/11/2020; 07/10/2020; 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 73