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

Model Number 20000ISM

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Cardiac Perforation (2513); Mitral Valve Insufficiency/ Regurgitation (4451)

Event Date 02/15/2023

Event Type  Injury  

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position.During procedure when attempting to open the implant and capture leaflets, the implant was unable to open (clasps were up).Instead of elongating, the implant would remain closed and move distally when rotating the paddle knob counterclockwise.When rotating the paddle knob clockwise, the implant returned to the delivery system.The paddle knob was rotated more than two times during these checks.The operator attempted to retract the closed implant into the guide sheath, which resulted in the guide sheath bowing.The implant was retracted until the clasps were inside the guide sheath and the implant was closed over the tip of the guide sheath.The device (implant and guide sheath) were then retracted through the interatrial septum.While retracting, it was observed that one paddle would enter the right atrium while one would stay in the left atrium.The implant was readvanced to attempt to retract both paddles through the septum simultaneously.The implant and guide sheath were retracted into the ivc.They attempted to elongate in the ivc but were unsuccessful.The implant and guide sheath were retracted through the femoral vein and out through the femoral access site without any alterations.The access site was closed with the standard s knot.Fluoroscopy with contrast showed no damage to the vasculature.Retrieving the implant in this way resulted in a shunt in the septum.The site did not feel the need to close the shunt with an occluder.It was unknown if any re-intervention was needed.The cardiologist wanted to continue the procedure with a second device, but the anesthesiologist did not want to continue to anesthetize the patient.Patient is doing well.No other patient consequences were reported.After image review, the fingers of the pascal ace device appear disengaged from the implant catheter and attached to the ace device at the proximal end of the device in the procedural tee.The ace device appeared attached by the actuation wire and sutures to the implant catheter.Prior to the finger disengagement air was visualized in the left heart.After the finger disengagement (during bailout attempt) a small, linear mobile echo density was visualized attached to the guide sheath tip.The ace device appeared successfully bailed out without device elongation.However, there was an 8 mm x 13 mm uni-directional inter-atrial septal shunt visualized after device bailout that was not visualized at baseline.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Other serious- shunt in the septum.Although no information on re-intervention, there is potential for re-intervention in this case.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Event Description

Additional information received stated that the patient was stable, and site had plans for another transcatheter edge to edge repair procedure (teer).

Manufacturer Narrative

The planned intervention is not to treat the residual shunt from the original procedure as the patient was and remains asymptomatic.However, the additional teer procedure is to treat residual mitral regurgitation due to the malfunction of the device that led to bailout and subsequent aborted procedure.

Manufacturer Narrative

The complaint was confirmed with objective evidence via imaging and the returned complaint sample.Visual inspection of the complaint unit identified witness marks on the shaft, which suggested that torsional load was applied.Review of the complaint file did not indicate direct torque applied to the attachment finger joint, however during the procedure, after the implant fully exited the guide sheath and closed, the physician was instructed to rotate the guide sheath such that the flushport was rotated from 3 o clock to 7 o clock (120 degree of rotation), prior to elongating the implant.Witness mark suggests that torque was applied to the attachment fingers during either device preparation or procedural use may have occurred.As part of the investigation, characterization of the shafts manufactured by te was performed and documented.Test results show that the manufacturing variation at te in addition to the torque applied to the attachment fingers by operators are potential root causes to finger detachment for this complaint.However, this was not determined to be the definitive root cause for this single event and a capa was referenced in this regard.

• 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: 16524910
• MDR Text Key: 311130856
• Report Number: 2015691-2023-11392
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)231213
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2023

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: 12/13/2023
• Device Model Number: 20000ISM
• Device Catalogue Number: 20000ISMA
• Device Lot Number: 10339463
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/07/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/15/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/27/2023; 05/16/2023
• Supplement Dates FDA Received: 04/07/2023; 05/16/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/13/2022
• 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: 79 YR
• Patient Sex: Male