MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS TRANSCATHETER VALVE UNKNOWN; PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED

Model Number VALVE UNKNOWN

Device Problems Device Dislodged or Dislocated (2923); Infusion or Flow Problem (2964)

Patient Problem Injury (2348)

Event Date 11/01/2010

Event Type  Injury  

Manufacturer Narrative

The date of the events is unknown.According to the article all implants were completed between november 2010 to march 2019.For this reason, the first day of the range was used as the occurrence date.The exact valve model number is not available.Therefore, sections d1 and d4 of this report will reflect an unknown edwards transcatheter heart valve.The possible pma numbers associated with this article are: p130009 - edwards sapien xt transcatheter heart valve and p140031- edwards sapien 3 transcatheter heart valve.Per the instructions for use (ifu), device embolization is a known potential complication associated with the transcatheter valve replacement procedure.There are multiple patient and procedural factors that alone or in combination can cause or contribute to valve embolization, including, but not limited to, improper positioning prior to deployment, poor image intensifier angle, poor coaxial alignment of the valve/delivery system, rapid deployment, movement of the delivery system by the operator, valve size mismatch, suboptimal implant location, and incomplete frame expansion.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 3 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 this case, there was no allegation or indication a product deficiency contributed to this adverse event.The cause of the valve embolization into the lungs cannot be determined, however, patient factors and or procedural factors may have contributed to the event.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.Reference article: alessia faccini, md luca giugno, md luciane piazza, md angelo f.D¿aiello, md francesca r.Pluchinotta, md massimo chessa, md, mario carminati, md, ¿evolving technique for sapien pulmonary valve implantation.A single-center experience " cardiovascular interventions (2020).

Event Description

As reported in the medical article, ¿evolving technique for sapien pulmonary valve implantation.A single-center experience¿, patients who underwent percutaneous pulmonary valve implantation with sapien valves, between (b)(6) 2010 and (b)(6) 2019, two patients required urgent surgical intervention due to valve dislodgement and right pulmonary artery flow exclusion.

• Brand Name: EDWARDS TRANSCATHETER VALVE UNKNOWN
• Type of Device: PROSTHESIS, MITRAL VALVE, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA
• Manufacturer (Section G): EDWARDS LIFESCIENCES LLC; 1 edwards way; irvine CA 92614
• Manufacturer Contact: renee dorne ; 1 edwards way; irvine, CA 92614 ; 9492506385
• MDR Report Key: 10662670
• MDR Text Key: 211020407
• Report Number: 2015691-2020-13932
• Device Sequence Number: 1
• Product Code: NPU
• Combination Product (y/n): N
• Reporter Country Code: IT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/17/2020

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
• Device Operator: Health Professional
• Device Model Number: VALVE UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/17/2020
• Initial Date FDA Received: 10/12/2020
• 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