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

Model Number	MCS-P3-29-AOA-US
Medical Device Problem Code	Gradient Increase (1270)
Health Effect - Clinical Codes	Thrombosis (2100); Regurgitation, Valvular (2335)
Date of Event	06/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that approximately four years, 11 months and 26 days following the implant of this 29 millimeter (mm) transcatheter bioprosthetic valve, the patient presented with increased gradient and possible aortic insufficiency.A computed tomography angiography (cta) was performed along with an echocardiogram which revealed leaflet thrombosis on all three bioprosthetic valve leaflets.It was reported that the thrombosis was also causing the severe aortic insufficiency.A 26 millimeter (mm) transcatheter bioprosthetic valve was implanted valve in valve.Following the valve in valve implant, the aortic insufficiency had resolved and there was no gradient on the final hemodynamic measurements.No additional adverse patient effects were reported. .
Additional Manufacturer Narrative
Additional information was received which indicated that the final implant depth of the valve was approximately 13 to 14 millimeter (mm) on the non-coronary cusp (ncc) and 18 to 19 mm on the left coronary cusp (lcc).It was reported that central aortic insufficiency was reported from one of the bioprosthetic valve leaflets being propped open.The gradient when the thrombus was detected was approximately greater than 40 mmhg.It was reported that the patient did not have any pre-existing coagulopathy issues or other blood disorders.Anticoagulation therapy was given when the patient¿s gradient increased with the suspicion of leaflet thrombosis.No additional adverse patient effects were reported.  the event date has been updated in section b.2.3.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.
Additional 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.High gradients increase over time are typically related to patient factors such as, but not limited to, thrombus formation, calcification, patient pressures, and/or anatomical left ventricular outflow tract (lvot) obstruction, etc.In addition, aortic insuffiency can be caused by a variety of factors, including valve positioning, patient anatomy, calcification level or presence of pre-existing patient conditions.In this case, the report indicates that the computed tomography angiography (cta) revealed leaflet thrombosis on all three bioprostethic valve leaflets.It is known that thrombus formation may lead to decreased leaflet mobility leading to valve stenosis and high gradient, which might had occurred in this event.It was reported that the thrombosis was also causing the severe aortic insufficiency.Several factors can affect the creation of thrombus, including medications, peri-procedural injury, and pre-existing patient conditi ons, and its presence and rate of formation is largely dependent on patient condition.Abnormal blood flow, other likely factor in the formation of the thrombus, may also be related to patient factors such as atrial fibrillation and left ventricular dysfunction that may cause turbulent flow or areas of stasis.Abnormal blood flow can also occur if the valve is unable to fully open and close as designed (reduced leaflet mobility), leading to blood stasis in the cusps of the leaflets.Reduced leaflet mobility may be related to distortion of the transcatheter aortic valve (tav) in the region of the tissue valve which, in turn is related to the placement of the bioprosthesis.The reported high gradient, a pressure differential across the valve, could potentially be related to placement of the tav, as it generally occurs due to leaflet mobility and/or a reduced orifice area.The tav has been studied for optimal in-vitro performance based on optimal placement.In-vivo misaligned placement can potentially lead to reduced leaflet mobility.To properly place the corevalve, the tissue valve region is placed supra-annular, as this reduces the effect that the shape of the existing anatomy has on leaflet movement and allows for the greatest orifice area.If the valve is implanted too deep, the tissue valve re gion can sit in contact with the anatomy and will distort to the existing shape of the valve.Per the corevalve instructions for use (ifu), the bioprosthesis should be placed so that the skirt is within the aortic annulus (approximately 4 mm to 6 mm below the annulus).It was reported that the final implant depth of this valve was approximately 13 to 14 mm on the non-coronary cusp (ncc) and 18 to 19 mm on the left coronary cusp (lcc), too deep/sub optimal position.In summary, the cause of the high gradients and thrombosis seen in this event appears to be related to the distortion of the valve, possibly as a result of implanting the valve in a sub optimal position.May optimal positioning is necessary for the valve to perform properly.Pre-existing patient conditions may also have been a factor in the formation of the thrombosis, but no information was able to be obtained to confirm the existence of these conditions.It was reported that the patient did not have any pre-existing coagulopathy issues or other blood disorders.Anticoagulation therapy was given when the patient¿s gradient increased with the suspicion of leaflet thrombosis.However, as the device remains implanted, and the echocardiography images were not provided for review, therefore a conclusive root cause could not be determined.In this case, a 26 millimeter (mm) valve was implanted valve in valve.This event does not indicate device misuse or malfunction.Updated data; h,6 eval method, eval results, eval conclusion codes.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: COREVALVE TRANSCATHETER AORTIC VALVE
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 10145399
• Report Number: 2025587-2020-01867
• Device Sequence Number: 11725581
• Product Code: NPT
• UDI-Device Identifier: 00643169448544
• UDI-Public: 00643169448544
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P130021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/16/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/26/2017
• Device Model Number: MCS-P3-29-AOA-US
• Device Catalogue Number: MCS-P3-29-AOA-US
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2020
• Supplement Date Received by Manufacturer: 06/11/2020; 09/11/2020
• Initial Report FDA Received Date: 06/11/2020
• Supplement Report FDA Received Date: 06/25/2020; 09/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 110