MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION COREVALVE 29MM AORTIC VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number MCS-P3-29-AOA

Device Problems Device Operates Differently Than Expected (2913); Insufficient Information (3190)

Patient Problems Aortic Regurgitation (1716); No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2014

Event Type  Injury  

Event Description

Medtronic received information that following the implant of this transcatheter bioprosthetic valve, severe central regurgitation was noted.A second corevalve was implanted valve in valve which resolved the regurgitation.No adverse patient effects were reported.Transesophageal echocardiogram (tee) during the procedure showed the central leakage, in the shape of one leaflet.Procedural films have been requested but not received.

Manufacturer Narrative

Product analysis: the product remains implanted, therefore no product analysis can be performed.Conclusion: based on the information provided, the reported aortic regurgitation that required reintervention could possibly be related to patient anatomy and/or implant position.Positioning is dependent on patient anatomy as well as user technique.Potential factors that can influence implant position include tension applied on the delivery catheter system (dcs) during positioning, calcification levels in the native vessel and compliance of the aorta and native vessels.The procedure was successfully completed with no adverse patient effects reported.The root cause for this report could not be established from the information available.Should additional information be obtained, a supplemental report will be submitted.(b)(4).

Manufacturer Narrative

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.Per the angiographic report, post-implantation aortography revealed an implantation depth of approximately 10mm with moderately-severe to severe (grade 3+ to 4+) aortic regurgitation.Some of the regurgitation appeared to be paravalvular leakage in the area of the non-coronary cusp.Post-implantation dilatation of the first device was performed and subsequent aortography demonstrated a slight improvement in aortic regurgitation.Given the angiographic view that was provided, it was not possible to appreciate whether paravalvular leakage was present.After the post-implantation dilatation, the source of the aortic regurgitation could have been central or paravalvular.A second corevalve was implanted approximately 4 mm higher than the first corevalve.No aortography was documented following this second device implant.The procedural echocardiogram was reviewed and confirmed regurgitation after the first valve was implanted.Per the echocardiogram it appeared to be a transvalvular/central eccentric flow.Artifact made it difficult to quantify the amount of regurgitation.The severe regurgitation was confirmed after the first valve was implanted through the imaging review.The first valve was implanted deep at 10mm, and this could contribute to paravalvular and/or central leakage.The angiographic review was not able to discern the central regurgitation from the paravalvular leakage.The angiographic review did not show any anomalies to explain the regurgitation.As the device was not explanted, no analysis was performed and a conclusive cause could not be determined.The severe regurgitation was resolved with the successful implant of a second valve.The devices remain implanted.No other adverse effects were reported.Medtronic will continue to monitor for similar events.

Manufacturer Narrative

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

• Brand Name: COREVALVE 29MM AORTIC VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• 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: 3821727
• MDR Text Key: 4398137
• Report Number: 2025587-2014-00311
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P130021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,company representati
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: MCS-P3-29-AOA
• Device Catalogue Number: MCS-P3-29-AOA
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2014
• Initial Date FDA Received: 05/20/2014
• Supplement Dates Manufacturer Received: Not provided; 07/02/2014
• Supplement Dates FDA Received: 07/09/2014; 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/11/2014
• 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