MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION LOTUS EDGE VALVE SYSTEM; LOTUS EDGE TM VALVE SYSTEM

Model Number	H749LVSUS230
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914)
Date of Event	08/19/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that hypotension, and cardiac arrest occurred.The procedure was indicated in order for the patient to be eligible for pulmonary vasodilator therapy for pulmonary hypertension.Vascular access was obtained via a left transfemoral approach.The anatomy contained mild to moderate calcium with a heavy calcium in the sinotubular junction (stj).A 23mm lotus edge valve was advanced to treat the native aortic valve.Upon locking of the 23 mm lotus edge valve, the patient's blood pressure dropped.Moderate paravalvular leak (pvl) was observed.The degree of pvl was not consistent with the patient's degree of hypotension.The 23mm lotus edge valve had a noticeable waist at the annular level and was well anchored.The patient's pulse was lost and required one minute of cardiopulmonary resuscitation (cpr).Several vasopressor medications were given, then bypass cannulae were placed in both groins and a pump was placed.Just prior to going on the pump, the patient's systolic blood pressure was 160, cardiac function returned to near baseline and restoration of the patient's pulse.The patient was intubated.The procedure continued with the removal of the 23mm lotus edge valve.At some point, during the procedure, it was noticed that the patient's right ventricle permanent pacemaker lead was dislodged.A pacing swan line was placed in the pulmonary artery.A 25mm lotus edge valve was then placed with good position and trace pvl.After the successful implant of the 25mm lotus edge valve, the patient was taken off the pump, remained intubated and was sent to the icu.In the physician's opinion, the patients pulmonary hypertension and high pulmonary vascular resistance contributed to the cardiac arrest.The physicians believe the hypertension during the deployment of the 23mm lotus edge valve was likely due to the decreased output state caused by the patient's known severe pulmonary hypertension and not caused by the 23mm lotus edge valve.The patient had very little cardiac reserve.The patient has been able to be extubated and discharged to the floor.The patient is doing well and expected to be discharged.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Common Device Name: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10502183
• Report Number: 2134265-2020-12206
• Device Sequence Number: 2757362
• Product Code: NPT
• UDI-Device Identifier: 08714729960904
• UDI-Public: 08714729960904
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/29/2020
• Device Model Number: H749LVSUS230
• Device Catalogue Number: H749LVSUS230
• Device Lot Number: 0024842193
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/19/2020
• Initial Report FDA Received Date: 09/08/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR