MAUDE Adverse Event Report: MEDTRONIC HEART VALVE DIVISION OPEN PIVOT MECHANICAL HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 500DM25

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 08/16/2019

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 during the implant of this mitral mechanical valve, upon final suturing and positioning, one of the valve leaflets broke.The valve was explanted and replaced with a valve of the same size and model.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, the valve was slightly discolored and damage to the sewing cuff, which likely occurred during explant, was observed.The valve was received with one leaflet attached.The attached leaflet was in the closed position.The attached leaflet was intact with no evidence of damage such as cracks and/or surface anomalies.A detached leaflet was received with the valve for analysis.The detached leaflet was determined to be the left leaflet.No evidence of damage such as cracks and/or surface anomalies were observed on the detached leaflet.Both inflow and outflow valve hinge mechanisms were intact with no evidence of damage.A blue actuator was used to test leaflet movement, the attached leaflet moved without difficulty.The valve was rinsed under tap water and it was verified that the carbon subassembly rotated in the sewing ring.The device was sent for further assessment.Several component critical dimensions (leaflets and orifice) were re-measured.The re-measured dimensions were within specification.The critical valve assembly dimension, crown-to-notch, which is part of the design that secures the leaflets and prevents the leaflets falling out, was also re-measured and determined to be within design specification.Therefore, it was confirmed that the device met all applicable manufacturing specifications.Conclusion: the device history record (dhr) 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 visual inspection and dimensional analysis, it was concluded that the device met all applicable manufacturing specifications when released for distribution.After a thorough review of the information received from the facility, manufacturing evaluation, dhr review, as well as review of the existing device design, a root cause for the leaflet detachment during implant could not be identified.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.Implant techniques such as using other instruments for valve rotation, applied excessive force while rotating the valve leaflets, rotating the valve using the leaflet rather than using the rotator, handling/pulling the valve by grasping the leaflet, holding and compressing (pinching) the valve by contacting the ¿non-pivot areas¿ of the valve.Coding updated in h6.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: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 8990896
• MDR Text Key: 157393172
• Report Number: 3008592544-2019-00044
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/10/2021
• Device Model Number: 500DM25
• Device Catalogue Number: 500DM25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2019
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR