MAUDE Adverse Event Report: EDWARDS LIFESCIENCES CERTITUDE DELIVERY SYSTEM AND CERTITUDE INTRODUCER SHEATH SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number	9630TA29A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Per the instructions for use (ifu), valve embolization is a known potential complication associated with the transcatheter aortic valve replacement (tavr) procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to ventricular embolization, including improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, a narrow, calcified sinotubular junction, minimally or bulky/severely calcified aortic leaflets, rapid deployment, release of stored tension during deployment, and movement of the delivery system by the operator.The thv training manuals instruct the operator on proper positioning and deployment of the valve, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the sapien thv.Training includes patient screening, device preparation, approach, deployment, imaging, procedure-specific training manuals and proctored procedures.The correct alignment and positioning of the device at the point of deployment is emphasized as a key factor to the placement and fixation of the device.Operators are also instructed to use fluoroscopy as the primary method of visualization for positioning and deployment.In patients with high-risk anatomical features for ventricular embolization (i.E.Small, calcified stj, minimal leaflet calcification), bav may provide indication of potential balloon movement during valve deployment.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.Investigation results indicate that the valve got caught on the lvot calcium and was stripped off the delivery system and embolized into the lvot.The root cause of the event was likely due to patient and procedure related factors.The ifu and training manuals have been reviewed and no inadequacies have been identified with regards to warnings, contraindications, and the directions/conditions for the successful use of the device.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.No corrective or preventative actions are required.
Event or Problem Description
Edwards received notification from an field clinical specialist that an sapien 3 valve was stripped off the delivery system and embolized into the left ventricular outflow tract(lvot).As reported, this patient was a ta approach due to significant calcium burden at the other alternate access sites.There was a heavy calcium burden at the lvot.During the ta approach with the certitude delivery system, the physicians felt that the valve got caught on the lvot calcium.When the physician tried to pull back the system and reposition it, the valve was stripped off the delivery system and embolized into the lv.Emergent ecmo was initiated.The physician was able to retrieve the embolized valve through the ta incision and a new sheath, certitude delivery system and valve were used to complete this procedure.The patient remained under critical observation in the ccu.The last known status is that patient is doing well.
Additional Manufacturer Narrative
Supplemental report submitted to correct b1 and b2.

• Brand Name: CERTITUDE DELIVERY SYSTEM AND CERTITUDE INTRODUCER SHEATH SET
• Common Device Name: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; one edwards way; irvine CA 92614
• MDR Report Key: 11586715
• Report Number: 2015691-2021-02142
• Device Sequence Number: 4108280
• Product Code: NPT
• UDI-Device Identifier: 00690103201451
• UDI-Public: (01)00690103201451(17)220603(10)63198562
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2021

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: 06/03/2020
• Device Model Number: 9630TA29A
• Device Catalogue Number: 9630TA29A
• Device Lot Number: 63198562
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/01/2021
• Initial Report FDA Received Date: 03/29/2021
• Supplement Report FDA Received Date: 04/09/2021
• 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