MAUDE Adverse Event Report: EDWARDS LIFESCIENCES EDWARDS PASCAL PRECISION; MITRAL VALVE REPAIR DEVICES

Model Number 20000IS

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

Patient Problem Stroke/CVA (1770)

Event Date 03/01/2023

Event Type  Death  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.H3 other text : implanted.

Event Description

Edwards received notification of a pascal in mitral position through review of medical article -versacross transseptal system for mitral transcatheter edge-to-edge repair with the pascal repair platform where a patient with a pascal device implanted in mitral position experienced a late stroke after an implant duration of 36 hours.Patient subsequently died before discharge.The embolic stroke was attributed to atrial fibrillation, a difficult procedure with multiple repositionings and the pascal device itself.Transseptal puncture (tsp) was performed with a novel radiofrequency solution named versacross.

Manufacturer Narrative

The complaint for thrombus formation was unable to be confirmed based on the available information.However, this is insufficient information to determine the cause of this event.The complaint review and analysis of all available information fails to indicate a root cause or probable root cause.Unable to determine the cause of the event.Various factors that may contribute to an indeterminable root cause include, but are not limited to, no adequate imaging available, no product return, and no additional information from the site.Based on extensive complaint investigations and reviews, it has been identified that events are not associated with device malfunctions or manufacturing nonconformances.Per the instructions for use (ifu), intracardiac thrombus formation and device thrombosis are known potential adverse events which have been identified as possible complications associated with standard cardiac catheterization procedures.Potential patient risk factors such as atrial fibrillation, systemic disease (e.G., systemic lupus erythematosus, inflammation, and damage to various body tissues, including joints, skin, kidneys, heart, lungs, blood vessels, and brain), valvular disease itself and reduced cardiac ejection fraction can contribute to increased risk of thrombus/thrombosis.These events will continue to be monitored and complaints trending, and control limits are managed and assessed.

Manufacturer Narrative

Upon further review, the event date was updated to reflect the literature article submission date as the true event date is unknown and date of death is also unknown.Article citation: doshi sn, savvoulidis p, mechery a, lawton e, nadir ma.Versacross transseptal system for mitral transcatheter edge-to-edge repair with the pascal repair platform.Struct heart.2023 jun 22;7(6):100203.Doi: 10.1016/j.Shj.2023.100203.Pmid: 38046864; pmcid: pmc10692349.

• Brand Name: EDWARDS PASCAL PRECISION
• Type of Device: MITRAL VALVE REPAIR DEVICES
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer (Section G): EDWARDS LIFESCIENCES; 1 edwards way; irvine CA 92614
• Manufacturer Contact: cassandra cook ; 1 edwards way; irvine, CA 92614 ; 5743778277
• MDR Report Key: 18761216
• MDR Text Key: 336020603
• Report Number: 2015691-2024-01230
• Device Sequence Number: 1
• Product Code: NKM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P220003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

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: 20000IS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 02/27/2024; 02/27/2024
• Supplement Dates FDA Received: 02/27/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death