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

Model Number 20000GS

Device Problem Air/Gas in Device (4062)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2024

Event Type  malfunction  

Event Description

Edwards received notification of a pascal precision ace procedure in tricuspid position.Clinical specialist (cs) prepared the guide sheath (gs) as usual and being ifu compliant.After inserting the implant system (is) into the gs with the loader, the loader was retracted, and the physician wanted to aspirate blood, but this did not work.At first there was blood with many bubbles coming out, then it turned to more air.The physician advanced and retracted the is a bit forward and backwards and then tried aspirating after each little change, but it did not get any better.The doctor aspirated very slowly and carefully.The cs said that in this case the is had to be pulled out safely with the loader and exchange the gs.The physician refused to do so multiple times.The procedure was finished with the broken gs and two pascals implanted.No patient harm occurred and there was no air inside the heart.For safety reasons, the gs was not flushed with nacl to prevent the air in the flushport going into the heart.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: 2024-01715-01.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 in the us, addressing degenerative mitral regurgitation.But, it is approved for both tricuspid and mitral spaces in the region where the procedure was performed.Therefore, deployment in the tricuspid position will not be considered off-label in this case.H3 other text : implanted.

Manufacturer Narrative

The following sections were updated/corrected/added: b4, d4, g3, g6, h2, h4, h6 and h10.The complaint for inadequate aspiration, air remaining in device during insertion was confirmed with other empirical evidence.The device was not returned for evaluation therefore an assessment could not be performed.No manufacturing non-conformities could be identified from the information provided.The investigation of other complaints with the same complaint codes having to do with guide sheath aspiration has revealed that delamination of the spine to shaft bond may be the cause, but a definite root cause is unable to be determined.No manufacturing, labeling, training, or ifu deficiencies were identified but a pra and a capa were issued for this.

• 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: 18711830
• MDR Text Key: 336097052
• Report Number: 2015691-2024-01029
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(17)240427
• 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
• Report Date: 03/19/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 04/27/2024
• Device Model Number: 20000GS
• Device Lot Number: 65021521
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/15/2024
• Supplement Dates Manufacturer Received: 03/18/2024
• Supplement Dates FDA Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2023
• 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 Age: 82 YR
• Patient Sex: Female