MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION MEDTRONIC HALL PROSTHETIC HEART VALVE; HEART-VALVE, MECHANICAL

Model Number A7700

Device Problem Gradient Increase (1270)

Patient Problem Corneal Pannus (1447)

Event Date 10/27/2015

Event Type  Injury  

Manufacturer Narrative

Date of event and explanted date are approximate, as these dates were not reported.Multiple attempts to obtain device return and additional information on this event have been unsuccessful.Without return of the product, no definitive conclusions can 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 following implant of this 20mm mechanical valve (implant duration unknown), the valve had pannus on the front as well as gradients of 87mmhg as measured by catheterization.The valve was explanted and replaced with a 21mm non-medtronic valve.No adverse patient effects were reported.

Manufacturer Narrative

Product analysis: a photo of the device was provided for analysis.Based on a review of the photo, the clinical observation of pannus was confirmed.Pannus overgrowth around the sewing ring and valve orifice could inhibit leaflet motion and lead to high gradients.Conclusion: without the return of the device, the conclusive root cause cannot be determined.Leaflet motion related risks are known risks with mechanical heart valves.

Manufacturer Narrative

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

• Brand Name: MEDTRONIC HALL PROSTHETIC HEART VALVE
• Type of Device: HEART-VALVE, MECHANICAL
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• 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: 5246394
• MDR Text Key: 32022228
• Report Number: 2025587-2015-01224
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P790018
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A7700
• Device Catalogue Number: A7700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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