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

Model Number 10418

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Atrial Fibrillation (1729); Bradycardia (1751); Cardiac Arrest (1762); Congestive Heart Failure (1783); Death (1802); Ventricular Tachycardia (2132); Blurred Vision (2137)

Event Date 10/08/2020

Event Type  Death  

Event Description

(b)(6) study.It was reported that left bundle branch block (lbbb), congestive heart failure (chf), atrial fibrillation, cardiac arrest, bradycardia, ventricular tachycardia, blurred vision and death occurred.The patient was enrolled into the reprise iv study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin.Loading doses of 325 mg of aspirin and 300 mg of clopidogrel were given the day of the procedure.A lotus introducer was placed and the aortic valve was treated with deployment of a 27 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).On the same day, post index procedure, electrocardiogram revealed the patient had developed lbbb along with premature supraventricular complexes.The patient was monitored with temporary transvenous pacing (tvp).The rhythm remained, so the tvp was removed and the patient was started on aspirin and plavix.A repeat electrocardiogram was performed that day which revealed sinus bradycardia with lbbb.The premature supraventricular complexes were no longer present.Of note, the bradycardia was transient and was not observed in subsequent findings.One day post index procedure, the patient was diagnosed with chf.No action was taken.Two days post index procedure, the patient was diagnosed with atrial fibrillation with rapid ventricular response (rvr).Amiodarone was initiated and hospitalization was further prolonged.Heparin was not initiated due to the patient's low platelets and retroperitoneal bleed.Four days post index procedure, the decision was made to stop amiodarone and start toprol and digoxin, as the patient's atrial fibrillation continued for over 48 hours.A repeat electrocardiogram was performed and showed atrial fibrillation with rvr, lbbb, and wide qrs syndrome.Since the patient's heart rate remained difficult to control, the decision was made to heparinize for attempted cardioversion.Five days post index procedure, the patient complained of blurry vision in their right eye and had developed significant bradycardia with rates down to 20 sec and subsequent cardiac arrest.Code was called and advanced cardiovascular life support (acls) was performed including shock for ventricular tachycardia.After 35 minutes of attempted resuscitation, no pulse was regained and the patient was pronounced dead.

Manufacturer Narrative

B5 describe event or problem: updated.

Event Description

Reprise iv post-market study it was reported that left bundle branch block (lbbb), congestive heart failure (chf), atrial fibrillation, cardiac arrest, bradycardia, ventricular tachycardia, blurred vision and death occurred.The patient was enrolled into the reprise iv study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin.Loading doses of 325 mg of aspirin and 300 mg of clopidogrel were given the day of the procedure.A lotus introducer was placed and the aortic valve was treated with deployment of a 27 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).On the same day, post index procedure, electrocardiogram revealed the patient had developed lbbb along with premature supraventricular complexes.The patient was monitored with temporary transvenous pacing (tvp).The rhythm remained, so the tvp was removed and the patient was started on aspirin and plavix.A repeat electrocardiogram was performed that day which revealed sinus bradycardia with lbbb.The premature supraventricular complexes were no longer present.Of note, the bradycardia was transient and was not observed in subsequent findings.One day post index procedure, the patient was diagnosed with chf.No action was taken.Two days post index procedure, the patient was diagnosed with atrial fibrillation with rapid ventricular response (rvr).Amiodarone was initiated and hospitalization was further prolonged.Heparin was not initiated due to the patient's low platelets and retroperitoneal bleed.Four days post index procedure, the decision was made to stop amiodarone and start toprol and digoxin, as the patient's atrial fibrillation continued for over 48 hours.A repeat electrocardiogram was performed and showed atrial fibrillation with rvr, lbbb, and wide qrs syndrome.Since the patient's heart rate remained difficult to control, the decision was made to heparinize for attempted cardioversion.Five days post index procedure, the patient complained of blurry vision in their right eye and had developed significant bradycardia with rates down to 20 sec and subsequent cardiac arrest.Code was called and advanced cardiovascular life support (acls) was performed including shock for ventricular tachycardia.After 35 minutes of attempted resuscitation, no pulse was regained and the patient was pronounced dead.It was further reported that one day post index procedure, the patient's hemoglobin levels were trending low and they had abdominal pain and dizziness.A ct scan revealed retroperitoneal hematoma.Vascular surgery was consulted and a conservative management was recommended.The patient was not bleeding at a rate consistent with an arterial hemorrhage and an injury might have occurred during initial sheath advancement or guidewire manipulation.In addition, the death certificate listed the primary cause of death as acute or chronic diastolic congestive heart failure as a consequence of morbid obesity.Other significant conditions include atrial fibrillation and retroperitoneal bleed.An autopsy was performed and the autopsy findings were unavailable prior to completion of cause of death.

Event Description

Reprise iv post-market study.It was reported that left bundle branch block (lbbb), congestive heart failure (chf), atrial fibrillation, cardiac arrest, bradycardia, ventricular tachycardia, blurred vision and death occurred.The patient was enrolled into the reprise iv study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was given and the patient was on a prior regimen of aspirin.Loading doses of 325 mg of aspirin and 300 mg of clopidogrel were given the day of the procedure.A lotus introducer was placed and the aortic valve was treated with deployment of a 27 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).On the same day, post index procedure, electrocardiogram revealed the patient had developed lbbb along with premature supraventricular complexes.The patient was monitored with temporary transvenous pacing (tvp).The rhythm remained, so the tvp was removed and the patient was started on aspirin and plavix.A repeat electrocardiogram was performed that day which revealed sinus bradycardia with lbbb.The premature supraventricular complexes were no longer present.Of note, the bradycardia was transient and was not observed in subsequent findings.One day post index procedure, the patient was diagnosed with chf.No action was taken.Two days post index procedure, the patient was diagnosed with atrial fibrillation with rapid ventricular response (rvr).Amiodarone was initiated and hospitalization was further prolonged.Heparin was not initiated due to the patient's low platelets and retroperitoneal bleed.Four days post index procedure, the decision was made to stop amiodarone and start toprol and digoxin, as the patient's atrial fibrillation continued for over 48 hours.A repeat electrocardiogram was performed and showed atrial fibrillation with rvr, lbbb, and wide qrs syndrome.Since the patient's heart rate remained difficult to control, the decision was made to heparinize for attempted cardioversion.Five days post index procedure, the patient complained of blurry vision in their right eye and had developed significant bradycardia with rates down to 20 sec and subsequent cardiac arrest.Code was called and advanced cardiovascular life support (acls) was performed including shock for ventricular tachycardia.After 35 minutes of attempted resuscitation, no pulse was regained and the patient was pronounced dead.It was further reported that one day post index procedure, the patient's hemoglobin levels were trending low and they had abdominal pain and dizziness.A ct scan revealed retroperitoneal hematoma.Vascular surgery was consulted and a conservative management was recommended.The patient was not bleeding at a rate consistent with an arterial hemorrhage and an injury might have occurred during initial sheath advancement or guidewire manipulation.In addition, the death certificate listed the primary cause of death as acute or chronic diastolic congestive heart failure as a consequence of morbid obesity.Other significant conditions include atrial fibrillation and retroperitoneal bleed.An autopsy was performed and the autopsy findings were unavailable prior to completion of cause of death.It was further reported that the autopsy noted the provisional diagnosis was left ventricular hypertrophy (590 gram heart), arteriolonephrosclerosis and evidence of heart failure with bilateral ventricular dilation, and stasis dermatitis of the lower extremities.The bioprosthetic valve was intact with no thrombus or tearing of the cusps.There was no evidence of a perivalvular infection or leak.

• Brand Name: LOTUS EDGE VALVE SYSTEM
• Type of Device: LOTUS EDGE TM VALVE SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10771054
• MDR Text Key: 214131498
• Report Number: 2134265-2020-15069
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• PMA/PMN Number: P180029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2021
• Device Model Number: 10418
• Device Catalogue Number: 10418
• Device Lot Number: 0025764826
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention
• Patient Age: 79 YR