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

Model Number 20000ISMCL

Device Problems Off-Label Use (1494); Appropriate Term/Code Not Available (3191); Activation Failure (3270)

Patient Problem Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 10/25/2022

Event Type  Injury  

Event Description

Edwards received notification of a pascal ace precision procedure in the tricuspid position.Final procedural tee tr result was mild to moderate.However, follow up tte showed an increase of tr to moderate to severe.Tte showed pascal is well situated on lateral leaflet and not moving independently of cardiac cycle but appears partially detached from septal leaflet.Patient is asymptomatic, no chest pain or complaints of increased doe.Plan is to continue to diurese and monitor.Event is ongoing.There are no plans for reintervention or further action to treat the tr at this time.There is no report of patient harm or injury.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: 2022-20114-01.The device remains implanted at the time of this event.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.It should be noted, the device was implanted in the tricuspid position.At this time, the pascal precision transcatheter valve repair system is only indicated for the native mitral valve, addressing degenerative mitral regurgitation.Therefore, deployment in the tricuspid position is considered off-label.The device remains implanted.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The post-procedural single leaflet device attached (slda) resulted in a suboptimal therapeutic outcome/ineffective procedure and is likely to require medical or surgical intervention (recurrent regurgitation).The pascal training manuals instruct the operator on proper positioning and deployment of the device, including all procedural and anatomical considerations.Physicians are extensively trained by edwards before they are qualified to use the pascal system.Training includes patient screening (to ensure leaflet anatomy is suitable for the device), 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 in conjunction with echocardiography for optimal visualization during positioning and deployment of the device.No manufacturing non-conformances were confirmed to be related or contributed to the complaint event.Therefore, no ifu training deficiencies were identified, and no corrective/preventative actions were required.

Event Description

Additional information received from 30-day tte showed that a pascal was securely attached to posterior leaflet but no longer attached to septal leaflet.Tr returned to baseline torrential grade.Patient was doing well, and diuretics were increased.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Based on internal imaging evaluation- slda was confirmed on the post procedure tte.The device appeared attached to the ptl and was no longer attached to the stl.There appeared to be a chordal attachment on the septal side.The device appeared mobile throughout the cardiac cycle without prolapse into the right atrium.The final residual tr appeared semi-quantitatively moderate to severe.The final tv mean inflow gradient measured 1 mmhg at a heart rate of 56 bpm.There did not appear to be a device related issue or malfunction.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

• 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: 15749542
• MDR Text Key: 306518590
• Report Number: 2015691-2022-09085
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103211900
• UDI-Public: (01)00690103211900(17)230901
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/12/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2023
• Device Model Number: 20000ISMCL
• Device Lot Number: 10040142
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/26/2022
• Initial Date FDA Received: 11/07/2022
• Supplement Dates Manufacturer Received: 11/08/2022; 12/01/2022
• Supplement Dates FDA Received: 11/17/2022; 12/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2022
• 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): Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 83 KG