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

Model Number 501DA20

Device Problems Material Fragmentation (1261); Material Split, Cut or Torn (4008); Separation Problem (4043)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/01/2018

Event Type  Injury  

Manufacturer Narrative

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 20mm mechanical valve, while parachuting the valve onto the annulus, a small piece of the valve broke and fell into the left ventricular outflow tract (lvot).The surgeon removed the piece and replaced the valve with an 18mm mechanical valve.No additional adverse patient effects were reported. .

Manufacturer Narrative

Product analysis: upon receipt at medtronic¿s quality laboratory, visual inspection showed tear-like damage on the sewing ring.Both leaflets were received in the closed position.The blue actuator was used to test leaflet movement and the leaflets moved as expected.Both leaflets were intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms were intact.A broken outflow aspect of the orifice, adjacent to the right leaflet, was observed.A crack adjacent to the break as well as damage near the break were noted.Small pieces (approximately 2mm and 1mm) of carbon were received, that were suspected to have come from the break.The carbon subassembly rotated as expected in the sewing ring.Conclusion: the investigation is still in progress.A supplemental report will be submitted upon completion of the investigation.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.The design intent of the stiffening ring is to maintain the circularity of the orifice, thereby keeping the leaflets securely in place inside the orifice.The leaflets were barely touching the orifice at the broken area; therefore, the leaflets most likely did not contribute to the broken orifice.After a thorough review of the information received from this complaint, manufacturing evaluation, device history review, as well as the existing device design, it was concluded that the broken orifice is not directly related to the leaflet design and manufacturing process.Therefore, it is suggested that the damage of the orifice would have likely happened outside of medtronic¿s control.Based on the historical finding, the damages on the orifice may have been caused by metal tool contact (i.E.Forceps).If such tools were used to hold or remove the valve during implant, it could potentially damage the orifice.However, with the available information, medtronic cannot determine the root cause of the broken orifice.Conclusion code updated.Medtronic, inc.(medtronic) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.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 in the time allotted and has provided as much information as is available to the company as of the submission date this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic or its employees 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 reporting pursuant to part 803.Medtronic objects to the use of these words and others like it 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.

• Brand Name: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 7919900
• MDR Text Key: 122092098
• Report Number: 3008592544-2018-00040
• 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
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2022
• Device Model Number: 501DA20
• Device Catalogue Number: 501DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2018
• Date Manufacturer Received: 02/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention