MAUDE Adverse Event Report: EDWARDS LIFESCIENCES UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Model Number VALVE UNKNOWN

Device Problems Material Perforation (2205); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Mitral Regurgitation (1964); Perforation (2001)

Event Date 08/06/2019

Event Type  Injury  

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case.  in this case, the exact valve model number is not available.Therefore, this report will reflect an unknown edwards sapien transcatheter heart valve.The possible pma numbers associated with an edwards sapien transcatheter heart valve are:  p130009 - edwards sapien xt¿ transcatheter heart valve; p140031- edwards sapien 3 transcatheter heart valve.The dates of the events are unknown; however, according to the article the study period was from august 2015 to september 2018.For this reason, the first day of the reported study period ((b)(6) 2015) was used as the occurrence date.Per the instructions for use (ifu), cardiovascular injury, including perforation or dissection of valvular structures [e.G.Injury to the mitral valve/ apparatus] is a known potential complication associated with the tavr procedure.  chordae tendinae rupture in tavr can occur during advancement of the guidewire, bav catheter, or delivery system and is most likely to occur with antegrade approaches, however, can occur with a retrograde approach.In some cases intervention may not be required; however, if the rupture is significant it typically results in profound mitral regurgitation and will require intervention to prevent permanent injury.Physicians are extensively trained by edwards before they are qualified to use the sapien transcatheter heart valve (thv).Training includes proper guidewire positioning, and careful manipulation of devices.Per the thv ta training manuals, after gaining lv access with the 0.035¿ soft guidewire, the wire should be jiggled under tee imaging of the mitral valve.  an increase in mr suggests wire entanglement in the mitral sub-valvular apparatus.  if entanglement is suspected, the guidewire should be completely removed from the ventricle; the operator should change direction of the needle and reinsert the guidewire into the ventricle, checking again for wire entanglement.The tf training manual also provides guidance for valve crossing and wire exchange: exchange 0.035¿ amplatz extra-stiff wire with pre-shaped distal end in left ventricle.Ensure guiding catheter is advanced upon wire exchange to ensure exchange wire does not get caught in the mitral chordae.In this case, there was no allegation or indication a device malfunction contributed to this adverse event. based on the limited information from the article, a cause of the mitral injury could not be determined.However, the mechanisms described above may have contributed to the event.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.Reference: ¿the results of transcatheter aortic valve implantation -tavr made full use of 4d-ct-¿ takaaki nagano, et al.Displayed at the 49th annual meeting of the japanese society for cardiovascular surgery, on 12-feb-2019.

Event Description

As reported by our affiliate in (b)(6) and through a presentation at the 49th annual meeting of the japanese society for cardiovascular surgery, on 12-feb-2019, information was received via written article, "the results of transcatheter aortic valve implantation -tavr made full use of 4d-ct-".The facility had executed a total of 103 tavr procedures from august 2015 to september 2018.The devices used were sapien xt and sapien 3.It is unknown if the event occurred to a sapien xt patient or a sapien 3 patient.This report will capture the 1 case of acute mitral valve regurgitation due to perforated anterior leaflet with conversion to open heart surgery.No additional details were provided regarding these events.

Manufacturer Narrative

This is one of three manufacturer reports being submitted for this case. please reference related manufacturer report no: (b)(4).

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: UNKNOWN EDWARDS SAPIEN TRANSCATHETER HEART VALVE
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 8928546
• MDR Text Key: 160233468
• Report Number: 2015691-2019-03168
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: VALVE UNKNOWN
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention