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

Model Number 20000GS

Device Problem Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Cardiovascular Insufficiency (4445)

Event Date 09/15/2023

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.

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where air bubbles were observed.First of all, the guide sheath (gs) was prepped and inserted over the guidewire through the septum according to the ifu.It was placed in a safe position in the left atrium without any contact to the wall.While the physician was retracting the dilator/guide wire, bigger air bubbles were seen in the echo.The clinical team stopped for a moment and proceeded with retraction and further bubbles were seen in the tee.As the physician removed the dilator from the guide, he put his finger on the end of the guide to block the seal.In the meantime, the echo physician found a bigger air bubble attached to the aortic root in the left atrium (la).At that point the blood pressure of the patient decreased to a low level which needed medication and supra was applied.This caused a short tachycardia and an inferior hypokinesis was seen and in addition the right ventricle got bigger and also pump function was limited for some time.It was decided to do a coronary angiography of both coronary arteries, but no obstructions could be seen.Meanwhile the patient was stabilized with the medication and blood pressure was again in a normal range.No st elevation was seen in the ecg.Since the air bubble was still attached to the aortic root in the same position, the physicians discussed for a moment to either leave it or trying to aspirate it out with a coronary catheter.The decision was to aspirate it out through the catheter.A 9fr sheath was placed in the pascal gs and through this sheath they pushed a coronary catheter towards the la.The pascal guide was placed in the direction of the air depot and while the judkins catheter came out of the guide.The physicians were able to place it above the bubble and aspirated the air successfully and completely.Since the patient was now in a stable condition the procedure continued and the mitral regurgitation could be addressed successfully with one ace device.The patient was transferred to icu for further monitoring.

Manufacturer Narrative

The complaint for device not completely de-aired during flushing and preparation was confirmed with objective evidence.No manufacturing non-conformities were found in the returned sample at this time.Available information suggests that variations in execution of procedural steps may have been a contributing factor.However, a definite root cause is unable to be determined.

Event Description

Edwards received notification of a pascal precision ace procedure in mitral position where air bubbles were observed.First of all, the guide sheath (gs) was prepped and inserted over the guidewire through the septum according to the ifu.It was placed in a safe position in the left atrium without any contact to the wall.While the physician was retracting the dilator/guide wire, bigger air bubbles were seen in the echo.The clinical team stopped for a moment and proceeded with retraction and further bubbles were seen in the tee.As the physician removed the dilator from the guide, he put his finger on the end of the guide to block the seal.In the meantime, the echo physician found a bigger air bubble attached to the anterior left atrial wall adjacent to the aorta in the left atrium (la).At that point the blood pressure of the patient decreased to a low level which needed medication and supra was applied.This caused a short tachycardia and an inferior hypokinesis was seen and in addition the right ventricle got bigger and also pump function was limited for some time.It was decided to do a coronary angiography of both coronary arteries, but no obstructions could be seen.Meanwhile the patient was stabilized with the medication and blood pressure was again in a normal range.No st elevation was seen in the ecg.Since the air bubble was still attached to the anterior left atrial wall adjacent to the aorta in the same position, the physicians discussed for a moment to either leave it or trying to aspirate it out with a coronary catheter.The decision was to aspirate it out through the catheter.A 9fr sheath was placed in the pascal gs and through this sheath they pushed a coronary catheter towards the la.The pascal guide was placed in the direction of the air depot and while the judkins catheter came out of the guide.The physicians were able to place it above the bubble and aspirated the air successfully and completely.Since the patient was now in a stable condition the procedure continued and the mitral regurgitation could be addressed successfully with one ace device.The patient was transferred to icu for further monitoring.

• 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: 17913877
• MDR Text Key: 325409630
• Report Number: 2015691-2023-16709
• Device Sequence Number: 1
• Product Code: NKM
• 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: 12/08/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 20000GS
• Device Lot Number: 65128729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/11/2023
• Supplement Dates Manufacturer Received: 10/17/2023; 12/08/2023
• Supplement Dates FDA Received: 11/02/2023; 12/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2023
• 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: 88 YR