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

Model Number	20000ISA
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional 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.
Event or Problem Description
Edwards received notification of a pascal in mitral position where the edwards team and the ic decided to bail out the ace device.When bailing out the ace, the ic had a difficult time elongating device all the way and the paddle knob bottomed out to the point where the physician could not counter clock/elongate device any further.The actuation wire was not seen to be detached on echo or fluoro.When device was safely removed from patient, it was noticed that the actuation wire was no longer attached.There was no harm caused to the patient.Additional information from a call with the site physician confirmed the sequence of events and suggested that the inability to elongate device may have potentially led to the actuation wire break.This information led to additional testing in product evaluation that was able to confirm the device malfunction of inability to elongate implant could lead to actuation wire break.
Additional Manufacturer Narrative
Another code applicable to investigation findings is: malfunction observed without conclusive finding.The complaint for actuation wire breaks during repositioning and unable to elongate implant to reposition was confirmed with objective evidence of the returned device.No manufacturing non-conformities were found in the returned sample, no manufacturing non-conformances were found and no labeling, training, or ifu deficiencies were identified.Available information was unable to determine the severity of damage on the implant catheter prior to bailout.During bail out in a clinical procedure, the implant system with the implant attached is pulled into the guide sheath soft tip and then out of the guide sheath proximal seal may undergo high tensile load, which the implant catheter may be subjected to high tensile load.The physician was noted to be shaking of how much force was required to retrieve the system into the guide sheath.Additionally, the device was able to complete device preparation and device insertion without any issues noted.The cause of the unable to elongate implant to reposition could not be conclusively determined.As a result of implant catheter damage the affected device was unable to fully elongate leading to excessive force required during bailout potentially resulting in an actuation wire break.

• Brand Name: EDWARDS PASCAL PRECISION
• Common Device Name: 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: 17999974
• Report Number: 2015691-2023-17045
• Device Sequence Number: 15273047
• Product Code: NKM
• UDI-Device Identifier: 00690103216943
• UDI-Public: (01)00690103216943(17)231103
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P220003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2023
• Device Model Number: 20000ISA
• Device Lot Number: 10248257
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/04/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 12/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown