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

Model Number 20000GS

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problems Air Embolism (1697); Transient Ischemic Attack (2109)

Event Date 01/18/2023

Event Type  Injury  

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint#: (b)(4).Outcomes attributed to adverse event: other serious- even though there was no reintervention, there is a potential for reintervention 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

Edwards received notification of a pascal precision procedure in mitral position.An air-related event occurred.After inserting the guide sheath (gs) into the left atrium (la) and retraction of the dilator, air bubbles were observed coming from the gs, into the la.The bubbles formed an echogenic structure close to the aorta.The physician steered the guide to the bubbles and aspirated the air into the guide.Ew guide sheath was used to aspirate the bubble.Post procedure it was noted that the patient required more time than usual to wake up.There were no signs of cerebral damage after finally waking.There was no further sequalae and the patient was released from the hospital.As per the doctor opinion, the "slow to wake up" was a consequence of air embolism into cerebral vasculature.After image evaluation, there appeared to be a 15mm x 7mm bright echogenic structure in the left atrium, near the ascending aorta during the procedural tee.The pascal device appears to be in stable position and final residual mr is qualitatively trace.

Manufacturer Narrative

The complaint for device not completely de-aired during flushing and preparation, air remaining in the device was confirmed with empirical evidence.The event description was reported to a clinical specialist from a physician/hospital staff.Because edwards personnel were present for the procedure, the device was not returned, and air was not conclusively visualized in the imaging evaluation, the complaint can only be confirmed with empirical evidence.No device was returned for physical evaluation for non-conformances.However, a dhr review of the lot in question revealed no non-conformances.Representative units were used in testing both for the air introduction test procedure (quantitative data results) and eva testing (qualitative results).Air introduction testing showed that air introduced by the system was within the range qualified per design verification testing.Eva testing demonstrated that the event description was unable to be recreated.Because the device was not returned, it could not be evaluated for non-conformances.Potential root causes for the presence of air may include: omission of a flushing/de-airing step improper stopcock/syringe technique device-related defect that could not be confirmed due to complaint units being discarded.However, a true 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: 16375554
• MDR Text Key: 309528878
• Report Number: 2015691-2023-10799
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(17)230719
• 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: 03/29/2023

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: 07/19/2023
• Device Model Number: 20000GS
• Device Lot Number: 64491746
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/31/2023
• Initial Date FDA Received: 02/14/2023
• Supplement Dates Manufacturer Received: 03/28/2023
• Supplement Dates FDA Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2022
• 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