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

Model Number 501DA20

Device Problems Crack (1135); Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 01/13/2020

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 an unknown duration post implant of this 20mm aortic mechanical valve, it was explanted and replaced with an unknown size valve.The reason for the replacement was the leaflet movement was rigid, (movement with force ), in the absence of any subvalvular obstruction.No additional adverse patient effects were reported.

Manufacturer Narrative

Medtronic received additional information that the 20mm valve was implanted and explanted during the same procedure.No additional adverse patient effects were reported.  d6/d7: 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.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 both leaflets were in the closed position and appeared intact with no evidence of damage such as cracks or surface anomalies.Using an actuator, the leaflets appeared to move without difficulty.The sewing ring appeared damaged, likely occurring during explant.A crack on the orifice near one of the hinge mechanisms was observed but did not impact the leaflet motion; the other hinge mechanisms appeared intact.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.Based on the historical finding, the damage on the orifice may have been caused by a 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.Based on the analysis, the complaint could not be confirmed and no evidence of a leaflet motion issue was noted.The cause of the leaflet motion cannot be determined.D10: device evaluation and return date updated h3: device evaluated? field has been updated coding updated field 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: AORTIC AP
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 9691071
• MDR Text Key: 182961862
• Report Number: 3008592544-2020-00008
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2023
• Device Model Number: 501DA20
• Device Catalogue Number: 501DA20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2020
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention