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

Model Number 500DM25

Device Problem Incomplete Coaptation (2507)

Patient Problem Dyspnea (1816)

Event Date 11/24/2014

Event Type  Injury  

Event Description

Medtronic received information that 25 months post implant (original indication for implant was severe calcific mitral stenosis) of this 25mm open pivot mechanical valve, the patient presented to the hospital with breathlessness.Testing revealed high gradient measurements of 18mm hg and noted one of the leaflets was not moving.Subsequently, the patient required emergency reoperation.The valve was explanted and replaced with a smaller 23mm non-medtronic device.It was reported that the explanted valve will be returned, however has yet been received.No other adverse patient effects were reported.

Manufacturer Narrative

The device has not yet been returned.Without the return of the product, no definitive conclusion can be made regarding the clinical observation.(b)(4).

Manufacturer Narrative

Additional information was received that pannus was noted on the explanted valve.Conclusion: 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.The device has not yet been returned.Without product return, a conclusive cause of the reported event could not be determined.The reported pannus growth may have hindered movement of the leaflet.This investigation will be reassessed if the device is returned for analysis.

Manufacturer Narrative

Analysis: the explanted valve was received at medtronic received in a semi-cloudy 0.2% glutaraldehyde solution in an explant jar.A visual examination of the device was performed upon receipt.Both leaflets appeared intact with no evidence of damage such as cracks and/or surface anomalies.Both inflow and outflow valve hinge mechanisms appeared intact.The inflow and outflow orifices appear intact with no evidence of damage.Remnants of green and white multifilament sutures remained attached to the existing sewing ring.Pannus overgrowth was observed covering the sewing ring on the outflow and inflow, extending slightly over the orifice on the outflow onto one leaflet.An unknown amount of pannus appears to have been removed on the inflow and outflow during explant; host tissue residue remains on the inflow surface of one leaflet.Conclusion: the pannus observed on the explanted valve would have significantly impaired the leaflet mobility and led to high gradients across the valve.Pannus overgrowth is associated with surgical valve replacement due to patient interaction or the healing response to the surgically implanted valve.Pannus overgrowth is an inherent risk of surgical valve replacement.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.

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: 4366532
• MDR Text Key: 5235688
• Report Number: 3008592544-2014-00042
• Device Sequence Number: 1
• Product Code: LWQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P990046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/19/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/24/2018
• Device Model Number: 500DM25
• Device Catalogue Number: 500DM25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 12/29/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; 01/19/2017
• Supplement Dates FDA Received: 01/26/2015; 01/25/2017; 09/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/19/2011
• 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: 00037 YR