MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS ESHEATH INTRODUCER SET; AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Embolism (1829)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Udi: unknown.The investigation is ongoing.

Event Description

As reported via a call to edward lifesciences,  8-9 days post right tf tavr the patient developed a rash on the right foot.An echo and doppler study on both legs performed showed normal results.A dermatologist performed a right foot punch biopsy of skin measuring 2x2x2mm. per the pathology report stated ¿there is basophilic material within a muscular blood vessel.¿ ¿this suggests an embolic phenomenon.¿ the patient was prescribed medication with instructions to stop plavix and the rash subsided. from last communication the patient is doing much better with no more rashes.

Manufacturer Narrative

Udi: unknown.  per the instructions for use (ifu), potential risks associated with the overall procedure include thrombus formation, plaque dislodgment, and embolization that may result in myocardial infarction, stroke, distal peripheral occlusion, and/or death.It is the natural tendency of the body to form clot on foreign objects in the vascular space.These patients are anticoagulated for the procedure and interventional best practices mandate meticulous wiping and flushing of the devices to prevent and/or remove clot.The thv training manuals and ifu instruct the operator to administer heparin and maintain the act at = 250 sec.In this case, there was no allegation or indication a device malfunction contributed to this adverse event.The exact cause for the ¿embolic phenomenon¿ could not be determined, however, procedural factors listed above and/or patient factors not provided 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.

• Brand Name: EDWARDS ESHEATH INTRODUCER SET
• Type of Device: AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• MDR Report Key: 10765375
• MDR Text Key: 214152359
• Report Number: 2015691-2020-14194
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P140031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other