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

Model Number 505D

Device Problem Mechanical Jam (2983)

Patient Problem Cardiomyopathy (1764)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

Product analysis: the product specimen is not available for device evaluation.Conclusion: a review of the device history record (dhr) was performed for this valve; there were no correlations / issues identified regarding manufacturing.The device was manufactured per approved and released manufacturing processes and the device met all applicable manufacturing specifications prior to release for distribution.The leaflet motion was obstructed due to patient native leaflet / implant technique.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.

Event Description

Medtronic received information that the patient presented with hypertrophic cardiomyopathy.The physican implanted this mechanical valve in the intra-annular position with the intent of preserving the posterior mitral leaflet (pml).Following the implant, a leaflet dysfunction was observed.The pml pushed into the leaflet and obstructed its movement.The device was explanted, the physician resected the pml, and a non-medtronic device was implanted.No other adverse patient effects were reported.

Manufacturer Narrative

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
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 6526899
• MDR Text Key: 73854526
• Report Number: 3008592544-2017-00024
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: 505D
• Device Catalogue Number: 505DM24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2015
• 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