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

Model Number 500DM

Device Problem Gradient Increase (1270)

Patient Problem Corneal Pannus (1447)

Event Date 08/27/2015

Event Type  Injury  

Manufacturer Narrative

No product has been returned.Without return of the product, no definitive conclusions could be drawn regarding the clinical observation.Should the device be returned or additional information become available, a supplemental report will be submitted.(b)(4).

Event Description

Medtronic received information that 8 years 3 months post implant of this mitral mechanical valve, the valve was explanted due to high gradients measured by echo and pannus ingrowth, causing a leaflet to stick.The valve was replaced with a bioprosthetic tissue valve.No further adverse patient effects were reported.

Manufacturer Narrative

Product analysis: the explanted device was not returned for analysis, however, a photo of the valve was received.Based on the review of the photo, the clinical observation (pannus) was confirmed.Pannus overgrowth was observed over the sewing ring and into the orifice of the valve, inhibiting leaflet motion.Conclusion: the restricted leaflet motion could lead to the reported high gradients.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: OPEN PIVOT MECHANICAL HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 5062487
• MDR Text Key: 25214801
• Report Number: 3008592544-2015-00036
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: Followup,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 500DM
• Device Catalogue Number: 500DM27
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/08/2015
• Supplement Dates Manufacturer Received: Not provided; 11/25/2015
• Supplement Dates FDA Received: 12/01/2015; 09/19/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 00059 YR
• Patient Weight: 83