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 Air Embolism (1697)

Event Date 09/22/2023

Event Type  Injury  

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 : not returned.

Event Description

Edwards received notification of a pascal precision procedure in mitral position where the functional mr grade was 3 with tethered leaflets.The transeptal puncture was completed with no incident.On removal of the dilator back into guide catheter, the blood pressure (bp) suddenly dropped to 50mmhg from a starting bp of 109/76.It was checked to see if there was a pericardial effusion but there was not one.Bp continued to crash to 40mmhg, and the right ventricle (rv) was noted to dilate with no contraction.Cpr was commenced and adrenaline was administered.Bp was eventually stabilized, and rv, lv contraction improved.Coronary arteries were examined by angiography, and they were fine.There were ecg changes with widening of the qrs complex noted.There was no obvious st elevation that was noted at the time of the event and ecg changes were seen following administration of adrenaline.The procedure was recommenced without problem and device was deployed without further incidence.Patient was doing well following the procedure and was discharged home.It was felt that there must have been an air embolus with transient changes which then dispersed.The mr after the procedure was one.

Manufacturer Narrative

The complaint for device not completely de-aired during flushing and preparation was confirmed with other empirical evidence.The complaint was confirmed, however no manufacturing non-conformities could be identified.Available information suggests that variations in execution of procedural steps may have been a contributing factor to the reported event.However, a definite root cause is unable to be determined.

• 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: 17935016
• MDR Text Key: 325677095
• Report Number: 2015691-2023-16818
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(17)240629
• 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: 11/13/2023

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 Model Number: 20000GS
• Device Lot Number: 65166283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/22/2023
• Initial Date FDA Received: 10/13/2023
• Supplement Dates Manufacturer Received: 11/11/2023
• Supplement Dates FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female