MAUDE Adverse Event Report: MEDTRONIC, INC. OPEN PIVOT AP360 HEART VALVE; HEART-VALVE, MECHANICAL

Model Number 505DM26

Device Problems Incomplete Coaptation (2507); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 11/11/2020

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 3 days post implant of this 26mm mitral mechanical valve, it was explanted and replaced with a n on-medtronic product due to one of the valve leaflets not closing properly resulting in severe regurgitation.It was reported the patient was excessively overweight and anatomy was preventing the valve from closing properly.The physician reported there was no fault of the 26mm mechanical valve.No additional adverse patient effects were reported.

Manufacturer Narrative

Product analysis: upon receipt at medtronic's quality laboratory, visual examination revealed the sewing cuff appeared discolored showing evidence of blood contact with thrombotic host tissue.Both leaflets were received in the closed position with a slight gap between the leaflets.The leaflets appeared to move without difficulty when tested with an actuator.Both leaflets appeared intact with no evidence of damage such as cracks and/or surface anomalies.The orifice and inflow/outflow valve hinge mechanisms were assessed under magnification ranging from 0.8× to 5×.Thrombotic host tissue was present on the orifice and hinge mechanisms.The orifice was cleaned using isopropyl alcohol (ipa) and a cotton-tipped applicator.The orifice and both hinge mechanisms appeared intact with no defects observed.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.It was reported that there was no issue with the device.The reported thrombotic tissue is considered to be a patient-related condition.D9: device available for evaluation? updated 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.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 AP360 HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• MDR Report Key: 10959643
• MDR Text Key: 219916720
• Report Number: 3008592544-2020-00064
• 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: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 505DM26
• Device Catalogue Number: 505DM26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR
• Patient Weight: 140