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

Model Number 505DA26

Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983); Scratched Material (3020)

Patient Problems No Information (3190); Insufficient Information (4580)

Event Date 10/08/2020

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 26mm mechanical aortic valve, it was explanted and replaced with a no n-medtronic mechanical valve.The valve was rotated to resect a subvalvular membrane.When attempting to rotate the valve further, the valve would not turn.The physician used a soft rubber clamp to rotate the valve, and one of the leaflets came out of the hinge points.The other leaflet became stuck in place.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed that one leaflet remained attached to the valve while the other leaflet was returned separately.The sewing cuff appeared slightly discolored showing evidence of blood contact with multiple points of damage (cuts, tears) along the sewing cuff, possibly a result of the explant process.The detached leaflet exhibited a long surface scratch down the middle of one side and a small gouge mark on the straight edge.The attached leaflet appeared intact with no evidence of damage such as cracks or surface anomalies.One notch of the attached leaflet appeared dislodged from the hinge mechanism.The other notch remained attached to the hinge mechanism.The dislodgement between the leaflet and the hinge mechanism appeared to restrict the mobility of the attached leaflet.Traces of dry coagulated blood was observed on all hinge mechanisms.Both inflow and outflow valve hinge mechanisms appeared intact.The orifice appeared intact with no evidence of damage.The valve was rinsed under tap water and it was verified that the carbon subassembly rotated in the sewing ring.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 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, a leaflet falling out is not anticipated.Based on reported complaints, there is a very low occurrence rate of leaflet fell out during implant.Implant techniques listed below, could be important contributing factors for leaflet detachment during implant: (1) using other instruments for valve rotation, (2) applied excessive force while rotating the valve leaflets, (3) rotating the valve using a leaflet rather than using the rotator, (4) handling/pulling the valve by grasping the leaflet, and (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: 10708871
• MDR Text Key: 212257304
• Report Number: 3008592544-2020-00054
• 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
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/03/2023
• Device Model Number: 505DA26
• Device Catalogue Number: 505DA26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 80