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

Model Number 505DM24

Device Problems Inadequacy of Device Shape and/or Size (1583); Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 07/10/2018

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 immediately post implant of this mechanical valve, the valve was explanted and replaced with another device.The reason for replacement was not reported.No additional adverse patient effects were reported. .

Manufacturer Narrative

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 inspection showed the valve attached to a size 24 holder with no blood contact observed.Once removed from the holder, both leaflets were in the closed position.The blue actuator was used to test leaflet movement and the leaflets moved normally.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.The inflow and outflow orifices were intact with no evidence of damage.The carbon subassembly rotated normally in the sewing ring.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.The valve tissue inner annulus and outer diameters were measured and met the manufacturing specification for a size 24 mm valve.Based on the reported information, there were no alleged deficiencies related to product quality/performance or manufacturing process.The potential cause of the sizing issue may have been due to the patient anatomy.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Medtronic received additional information that the 24mm mechanical valve couldn't be implanted due to variations in the mitral annulus of the patient.The valve was replaced with a larger model and no adverse patient effects were reported. 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 HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC HEART VALVE DIVISION; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7812417
• MDR Text Key: 118101604
• Report Number: 3008592544-2018-00033
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: 505DM24
• Device Catalogue Number: 505DM24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/16/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 85