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

Model Number 20000ISM

Device Problems Difficult or Delayed Positioning (1157); Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Stroke/CVA (1770); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/22/2024

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.After the procedure the patient suffered a stroke and could not be taken of the ventilator.Patient was stable before the procedure.The procedure was difficult and long.The septum was thickened with growth on the fossa.Physicians had difficulties to make a good placement.It was no problem to go mid fossa, but the needle always stayed right at the anterior part of the fossa.The atrium of the heart was measured with a height of 30 mm from annulus to roof and 35mm from septum to wall.Trans-septal puncture (tsp) was performed with a height of 25mm.The clinical specialist advised the height was not enough, but it was dismissed.Guide sheath (gs) was inserted, and flex was added to get away from the aorta.The implant system (is) was inserted and due to the height, the device came out of the gs right above the valve, and the device was closed with clasp up.Gaining height was not possible and turning the gs clockwise was somehow prevented.It was tried to get down to the valve with the gs flexed, but due to the height, the valve was crossed when the device was opened.Again, a gaining height maneuver was not possible.Physician elongated the device and due to the limited space, it was needed to pull the device with clasps up into the gs to get it out of the valve.The is was bailed out and physician put a wire through the gs to keep the venous access.Gs was bailed out.A new is and gs were prepared.Physician tried to get a better tsp with a steerable needle.After 100 minutes, support from the head of the department was requested.A very experienced pascal implanter used the old puncture of the fossa and used the gaining height maneuver with a lot of force.It was visible in fluoro that the is jumped.Physician implanted a pascal ace in a2/p2.After release the mitral regurgitation (mr) was grade 2.Starting mr was grade 4 and the procedure was finished.During procedure patient had unstable blood pressure and low heart rate.There was a lot of movement from the pascal system on the heart wall due to limited space.Physicians were satisfied with the result but not with the procedure time (not due to the device but to the anatomical difficulties on the septum).During the procedure there were no issues while de-airing the gs and no air was observed to have entered to the patient.As reported, patient did not wake up and could not be taken of the ventilator.A ct scan was done in the evening after the procedure, and it showed no cerebral problem.Patient stayed on the ventilator and on post-op day 1, a second ct scan was done that showed a stroke.After the stroke was confirmed, there were no actions taken and it was decided just to wait.Later the patient was noted as to be awake and cognitive fully restored (speaks, eats and is on a normal hospital ward).The check-up ct was done and did not show any abnormalities anymore.It was unclear what the origin of the stroke was but the think that it was an air embolism.As per the ct scan report provided, periprocedural new disseminated ischemic stroke was confirmed, both hemispheres and cerebellum involved, different areas of the cerebral vasculature may have been affected (via bilateral internal carotid arteries, direct or via connection through circle of willis from vertebral artery/subclavian artery)- middle cerebral artery frontal left, temporal right, capsula interna right, posterior cerebral artery right, posterior inferior cerebellar artery left).Presumably smaller infarction sizes as it did not cause any increase in intracranial pressure/change of middle line.There was unclear etiology of cerebral embolism.As per internal imaging review of the very limited procedural tee, there is evidence of air bubbles in the left heart and aortic root during the procedure.Ekg is not recorded.The first pascal ace is bailed out.A second pascal ace is deployed in a stable position.The residual mr is indeterminate.

Manufacturer Narrative

The complaint for inadequate aspiration, air remaining in device during insertion was confirmed with objective evidence.No manufacturing non-conformities were identified from the imaging evaluation.The imaging evaluation documented evidence of air bubbles in the left heart and aortic root during the procedure but was unable to identify contributing factors to the presence of air bubbles.Available information suggests that procedural use (first physician: his thought was that the manipulations with the tsp and the device in the heart, especially with the gaining height maneuver with a lot of force that caused the is to jump, caused some tissue tear and the tissue embolized.Second physician: made an allegation of air embolism) may have contributed to the reported event for air embolism.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: 18936370
• MDR Text Key: 338070831
• Report Number: 2015691-2024-02116
• Device Sequence Number: 1
• Product Code: NKM
• UDI-Device Identifier: 00690103213324
• UDI-Public: (01)00690103213324(17)241130(11)231201
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20000ISM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2023
• 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): Hospitalization
• Patient Age: 85 YR
• Patient Sex: Male