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

Model Number 20000GS

Device Problem Device Difficult to Setup or Prepare (1487)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); Ischemia (1942)

Event Date 11/04/2022

Event Type  Injury  

Event Description

Edwards received notification of a pascal ace precision in the mitral position an air embolism occurred.The guide sheath (gs) and implant system were prepared according to ifu, deaired, and no damage was visible.Transseptal puncture required several attempts due to fibrous tissue.A bisping, needle tip wire was used.The gs was inserted over the wire and advanced into la.The gs was inserted over wire and advanced into la.The wire was pulled back into the tip of the gs for removal.When the dilator was pulled approximately halfway out of gs, a sudden drop in blood pressure (bp) and an st-elevation developed.In echo, no pericardial effusion was visible, but at the wall of ascending aorta stationary air bubble was seen, measured as 20x20x7 mm.Also, a reduced lv wall motion in the apical area was observed in the echo.Suprarenin was administered to try and stabilize the bp.The physician manually aspirated the air using a multi-purpose (mp) catheter over left femoral groin access.To further reduce the risk of any remaining air in the gs, the physician introduced the pascal implant system into the gs approximately 10 cm and continued with air aspiration and deairing according to ifu.No excessive air was visible while aspirating gs.The aspiration over the mp catheter stabilized the patient with normal blood pressure, and the baseline ecg returned to normal.The physician continued the implant procedure without changing the guide or implant system.The following implant was successful with no other unanticipated events.The patient showed no negative effects after the implant procedure.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).Once the product is received and evaluated, the investigation findings code will be updated.The manufacturer's investigation is ongoing.A follow-up report will be submitted when the manufacturer's investigation is complete.

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).The following sections were updated/corrected: b5, g3, g6, h2, and h10.H10: a supplemental mdr is submitted based on additional information received from edwards clinical specialist.The case occurred during a new site activation and the physician is a frequent mitraclip user.Heparine was administered regularly during the procedure and act measured approx.Every 20 minutes to keep the act >300.Lap was reduced down to <60mmhg systolic but overall very unstable and fluctuating.The patient condition is good and the physician was satisfied with the final outcome.

Event Description

Edwards received notification of a pascal ace precision in the mitral position an air embolism occurred.The guide sheath (gs) and implant system were prepared according to ifu, deaired, and no damage was visible.Transseptal puncture required several attempts due to fibrous tissue.A bisping, needle tip wire was used.The gs was inserted over the wire and advanced into la.The gs was inserted over wire and advanced into la.The wire was pulled back into the tip of the gs for removal.When the dilator was pulled approximately halfway out of gs, a sudden drop in blood pressure (bp) and an st-elevation developed.In echo, no pericardial effusion was visible, but at the wall of ascending aorta stationary air bubble was seen, measured as 20x20x7 mm.Also, a reduced lv wall motion in the apical area was observed in the echo.Suprarenin was administered to try and stabilize the bp.The physician manually aspirated the air using a multi-purpose (mp) catheter over left femoral groin access.To further reduce the risk of any remaining air in the gs, the physician introduced the pascal implant system into the gs approximately 10 cm and continued with air aspiration and deairing according to ifu.No excessive air was visible while aspirating gs.The aspiration over the mp catheter stabilized the patient with normal blood pressure, and the baseline ecg returned to normal.The physician continued the implant procedure without changing the guide or implant system.The following implant was successful with no other unanticipated events.The patient showed no negative effects after the implant procedure.Additional information was received from the clinical specialist, "the case occurred during a new site activation and the physician is a frequent mitraclip user.Heparine was administered regularly during the procedure and act measured approx.Every 20 minutes to keep the act >300.Lap was reduced down to <60mmhg systolic but overall very unstable and fluctuating.The patient condition is good and the physician was satisfied with the final outcome.".

Manufacturer Narrative

The event is captured by edwards lifesciences under complaint #: (b)(4).H10: a supplemental mdr is submitted based on the manufacturer's device evaluation.The complaint that the device was not completely de-aired during flushing and preparation was confirmed with objective evidence.The dhr review of the lot in question revealed no non-conformances.A lot history review did not reveal any related complaints initiated for other units in this lot.Product evaluation found no manufacturing non-conformities on the returned sample.The device was sufficiently flushed and aspirated during the pre-decontamination evaluation and passed hemostasis testing post-decontamination, indicating no leaks in the system.Air introduction testing produced air volumes that fell well under the product safety limit.Per the event description and follow-up conversations with the edwards clinical specialist, the air was visualized in the ascending aorta and was measured to be 20x20x7 mm during the procedure.Evaluation of returned imaging confirmed the presence of a long, linear echo density where air bubbles appeared to be originating.The measured volume correlates with an air volume of 2.8 ml, well above the average value of 0.1438 ml, as measured via air introduction testing on the returned complaint unit.The investigation findings did not lead to a clear conclusion about the cause of the reported adverse event.No procedural or device-related issues could be identified.

• Brand Name: PASCAL PRECISION SYSTEM
• 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: 15857344
• MDR Text Key: 304278693
• Report Number: 2015691-2022-09471
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213331
• UDI-Public: (01)00690103213331(11)220601(17)230601
• 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,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/30/2023

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: 06/01/2023
• Device Model Number: 20000GS
• Device Lot Number: 64326855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/23/2022
• Supplement Dates Manufacturer Received: 11/23/2022; 01/27/2023
• Supplement Dates FDA Received: 12/02/2022; 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2022
• 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
• Patient Outcome(s): Required Intervention