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

Model Number 10394

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

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Cardiogenic Shock (2262); Stenosis (2263); Blood Loss (2597)

Event Date 10/27/2020

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) clinical study.It was reported that vessel occlusion and myocardial infarction occurred.Procedure summary: a patient with moderate aortic calcification and severe tortuosity was selected for a transcatheter aortic valve replacement (tavr) procedure.Prior to the index procedure, heparin or another anticoagulant was given.A sentinel cerebral embolic protection system was positioned for neuroprotection.A lotus introducer sheath (lis) was placed, and then the native aortic valve was treated with balloon valvuloplasty using a 20mm non-boston scientific balloon, in accordance with the instructions for use(ifu).The aortic valve was treated with subsequent deployment of a 25 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus in accordance with the ifu.The sentinel embolic protection system was removed from the patient.It was noted that a large volume of calcified debris had been collected by the sentinel embolic protection system.At the end of the procedure, the patient was spatially and temporally oriented.The patient was transferred to the intensive care unit without neurological failures.Post procedure event summary: on the same day, while in the intensive care unit, the patient experienced sinus arrest.After about twenty minutes of cardiopulmonary resuscitation (cpr), the patients vital signs were stabilized.The patient was sent for coronary angiography.Diagnostic catherization revealed ostial left circumflex artery (lcx) occlusion with thrombus.Percutaneous coronary intervention (pci) was performed with the implant of two (2) stents.The patient was placed on extracorporeal membrane oxygenation (ecmo).The patient was diagnosed with anemia most likely due to capillary leak syndrome.The patient was transfused with four (4) units of platelets, two (2) units of fresh frozen plasma and six (6) units of packed red blood cells.One (1) day post index procedure, the patient was pronounced dead.The primary cause of death was anemia most likely due to capillary leak syndrome not related to the lotus edge valve.

Manufacturer Narrative

A1:patient identifier: (b)(6).E1 initial reporter phone number: (b)(6).H3 device eval by manufacturer: the lotus edge valve was implanted.No device was returned for analysis.Procedural imaging was provided to assist in the investigation and was reviewed by a boston scientific quality engineer.A review of the media identified no issues during the lotus edge valve implantation which could potentially have contributed to the complaint event.The media does not capture the advancement or withdrawal of the device.The lotus edge valve was initially placed deep in the left ventricular outflow tract (lvot) however, following repositioning the lotus edge valve was implanted with no issues.No issues were identified with the lotus edge valve which could potentially have contributed to the complaint event.However, an acute blockage is identified in the left circumflex (lcx).

Event Description

Respond edge post-market clinical study.It was reported that vessel occlusion and myocardial infarction occurred.Procedure summary: a patient with moderate aortic calcification and severe tortuosity was selected for a transcatheter aortic valve replacement (tavr) procedure.Prior to the index procedure, heparin or another anticoagulant was given.A sentinel cerebral embolic protection system was positioned for neuroprotection.A lotus introducer sheath (lis) was placed, and then the native aortic valve was treated with balloon valvuloplasty using a 20mm non-boston scientific balloon, in accordance with the instructions for use(ifu).The aortic valve was treated with subsequent deployment of a 25 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus in accordance with the ifu.The sentinel embolic protection system was removed from the patient.It was noted that a large volume of calcified debris had been collected by the sentinel embolic protection system.At the end of the procedure, the patient was spatially and temporally oriented.The patient was transferred to the intensive care unit without neurological failures.Post procedure event summary: on the same day, while in the intensive care unit, the patient experienced sinus arrest.After about twenty minutes of cardiopulmonary resuscitation (cpr), the patients vital signs were stabilized.The patient was sent for coronary angiography.Diagnostic catherization revealed ostial left circumflex artery (lcx) occlusion with thrombus.Percutaneous coronary intervention (pci) was performed with the implant of two (2) stents.The patient was placed on extracorporeal membrane oxygenation (ecmo).The patient was diagnosed with anemia most likely due to capillary leak syndrome.The patient was transfused with four (4) units of platelets, two (2) units of fresh frozen plasma and six (6) units of packed red blood cells.One (1) day post index procedure, the patient was pronounced dead.The primary cause of death was anemia most likely due to capillary leak syndrome not related to the lotus edge valve.It was further reported that: on the same day post index procedure, the patient was found to have gone into pulseless electrical activity.Cpr was started and lasted approximately 35 minutes, not 20 minutes as previously reported.During resuscitation, the patient was transferred to the cardiac catheter laboratory.Mechanical circulatory support was implemented prior to angiography not following as previously reported using endoarterial extracorporeal membrane oxygenation(va-ecmo).The previously reported coronary angiography also detected thrombotic burden up to the main stem.The previously reported pci also included thrombus aspiration.A total of three drug eluting stents(des) were implanted, not two as previously reported.The stents were implanted in the in the main stem, left anterior descending(lad) and lcx arteries.Post ecmo implantation and over further clinical course, a pronounced requirement for volume therapy was observed and substitution therapy was administered accordingly.The patient was too hemodynamically unstable during the entire inpatient stay on the intensive care ward for additional computerized tomography(ct) diagnostic testing.Despite the maximum catecholamine and volume therapy, hemodynamic stabilization was not possible.Hospitalization was prolonged.The previously reported anemia due to capillary leak syndrome is related to the lotus edge valve.

Event Description

Respond edge post-market clinical study.It was reported that vessel occlusion and myocardial infarction occurred.Procedure summary: a patient with moderate aortic calcification and severe tortuosity was selected for a transcatheter aortic valve replacement (tavr) procedure.Prior to the index procedure, heparin or another anticoagulant was given.A sentinel cerebral embolic protection system was positioned for neuroprotection.A lotus introducer sheath (lis) was placed, and then the native aortic valve was treated with balloon valvuloplasty using a 20mm non-boston scientific balloon, in accordance with the instructions for use(ifu).The aortic valve was treated with subsequent deployment of a 25 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus in accordance with the ifu.The sentinel embolic protection system was removed from the patient.It was noted that a large volume of calcified debris had been collected by the sentinel embolic protection system.At the end of the procedure, the patient was spatially and temporally oriented.The patient was transferred to the intensive care unit without neurological failures.Post procedure event summary: on the same day, while in the intensive care unit, the patient experienced sinus arrest.After about twenty minutes of cardiopulmonary resuscitation (cpr), the patients vital signs were stabilized.The patient was sent for coronary angiography.Diagnostic catherization revealed ostial left circumflex artery (lcx) occlusion with thrombus.Percutaneous coronary intervention (pci) was performed with the implant of two (2) stents.The patient was placed on extracorporeal membrane oxygenation (ecmo).The patient was diagnosed with anemia most likely due to capillary leak syndrome.The patient was transfused with four (4) units of platelets, two (2) units of fresh frozen plasma and six (6) units of packed red blood cells.One (1) day post index procedure, the patient was pronounced dead.The primary cause of death was anemia most likely due to capillary leak syndrome not related to the lotus edge valve.It was further reported that: on the same day post index procedure, the patient was found to have gone into pulseless electrical activity.Cpr was started and lasted approximately 35 minutes, not 20 minutes as previously reported.During resuscitation, the patient was transferred to the cardiac catheter laboratory.Mechanical circulatory support was implemented prior to angiography not following as previously reported using enoarterial extracorporeal membrane oxygenation(va-ecmo).The previously reported coronary angiography also detected thrombotic burden up to the main stem.The previously reported pci also included thrombus aspiration.A total of three drug eluting stents(des) were implanted, not two as previously reported.The stents were implanted in the in the main stem, left anterior descending(lad) and lcx arteries.Post ecmo implantation and over further clinical course, a pronounced requirement for volume therapy was observed and substitution therapy was administered accordingly.The patient was too hemodynamically unstable during the entire inpatient stay on the intensive care ward for additional computerized tomography(ct) diagnostic testing.Despite the maximum catecholamine and volume therapy, hemodynamic stabilization was not possible.Hospitalization was prolonged.The previously reported anemia due to capillary leak syndrome is related to the lotus edge valve.It was further reported that the subject did not receive any loading doses of antiplatelet medication prior to the procedure.On the same day post index procedure, the subject was found to have gone into a cardiogenic shock diagnosed by x ray, diagnostic catheterization and lab tests.At the time of reporting, the event was considered to be recovering.

Manufacturer Narrative

A1:patient identifier: (b)(6).B: adverse event or product problem: updated.E1 initial reporter phone number: (b)(6).H6: patient codes: updated.H3 device eval by manufacturer: the lotus edge valve was implanted.No device was returned for analysis.Procedural imaging was provided to assist in the investigation and was reviewed by a boston scientific quality engineer.A review of the media identified no issues during the lotus edge valve implantation which could potentially have contributed to the complaint event.The media does not capture the advancement or withdrawal of the device.The lotus edge valve was initially placed deep in the left ventricular outflow tract (lvot) however, following repositioning the lotus edge valve was implanted with no issues.No issues were identified with the lotus edge valve which could potentially have contributed to the complaint event.However, an acute blockage is identified in the left circumflex (lcx).

Manufacturer Narrative

A1:patient identifier: (b)(6).B: adverse event or product problem: updated.B6 relevant tests/laboratory data - updated.E1 initiorter phone number: (b)(6).H6: patient codes: updated to imdrf codes.H6 impact codes - updated to imdrf codes.H3 device eval by manufacturer: the lotus edge valve was implanted.No device was returned for analysis.Procedural imaging was provided to assist in the investigation and was reviewed by a boston scientific quality engineer and boston scientific medical director.The media does not capture the advancement or withdrawal of the lotus edge device.The lotus edge valve was initially placed deep in the left ventricular outflow tract (lvot) however, following repositioning the lotus edge valve was implanted with no issues.No paravalvular leak (pv)l is visible.The final completion angiograms are after the valve is released from the delivery system and only showing the valve.It demonstrates that the valve is in optimal annular position and does not have significant braid deformity.No aortic regurgitation or defects in coronary circulation can be seen.Ascending aorta has normal appearance.No aortic root extravasation is visible.No issues were identified with the lotus edge valve which could potentially have contributed to the complaint event.However, an acute blockage is identified in the left circumflex.A review of the media identified no issues during the lotus edge valve implantation which could potentially have contributed to the event.Computerized tomography (ct) scanned images provided show a tricuspid aortic valve morphology that is severely calcified.An eccentric annular calcification is also visible.The annulus has an area-derived diameter of 23.3 mm and a perimeter of 75mm.

Event Description

Respond edge post-market clinical study.It was reported that vessel occlusion and myocardial infarction occurred.Procedure summary: a patient with moderate aortic calcification and severe tortuosity was selected for a transcatheter aortic valve replacement (tavr) procedure.Prior to the index procedure, heparin or another anticoagulant was given.A sentinel cerebral embolic protection system was positioned for neuroprotection.A lotus introducer sheath (lis) was placed, and then the native aortic valve was treated with balloon valvuloplasty using a 20mm non-boston scientific balloon, in accordance with the instructions for use(ifu).The aortic valve was treated with subsequent deployment of a 25 mm lotus edge valve.Successful repositioning of the lotus edge valve involved partial re-sheathing of the lotus edge valve in the delivery system catheter and deployment into a more accurate position within the aortic annulus in accordance with the ifu.The sentinel embolic protection system was removed from the patient.It was noted that a large volume of calcified debris had been collected by the sentinel embolic protection system.At the end of the procedure, the patient was spatially and temporally oriented.The patient was transferred to the intensive care unit without neurological failures.Post procedure event summary: on the same day, while in the intensive care unit, the patient experienced sinus arrest.After about twenty minutes of cardiopulmonary resuscitation (cpr), the patients vital signs were stabilized.The patient was sent for coronary angiography.Diagnostic catherization revealed ostial left circumflex artery (lcx) occlusion with thrombus.Percutaneous coronary intervention (pci) was performed with the implant of two (2) stents.The patient was placed on extracorporeal membrane oxygenation (ecmo).The patient was diagnosed with anemia most likely due to capillary leak syndrome.The patient was transfused with four (4) units of platelets, two (2) units of fresh frozen plasma and six (6) units of packed red blood cells.One (1) day post index procedure, the patient was pronounced dead.The primary cause of death was anemia most likely due to capillary leak syndrome not related to the lotus edge valve.It was further reported that: on the same day post index procedure, the patient was found to have gone into pulseless electrical activity.Cpr was started and lasted approximately 35 minutes, not 20 minutes as previously reported.During resuscitation, the patient was transferred to the cardiac catheter laboratory.Mechanical circulatory support was implemented prior to angiography not following as previously reported using enoarterial extracorporeal membrane oxygenation(va-ecmo).The previously reported coronary angiography also detected thrombotic burden up to the main stem.The previously reported pci also included thrombus aspiration.A total of three drug eluting stents(des) were implanted, not two as previously reported.The stents were implanted in the in the main stem, left anterior descending(lad) and lcx arteries.Post ecmo implantation and over further clinical course, a pronounced requirement for volume therapy was observed and substitution therapy was administered accordingly.The patient was too hemodynamically unstable during the entire inpatient stay on the intensive care ward for additional computerized tomography(ct) diagnostic testing.Despite the maximum catecholamine and volume therapy, hemodynamic stabilization was not possible.Hospitalization was prolonged.The previously reported anemia due to capillary leak syndrome is related to the lotus edge valve.It was further reported that the subject did not receive any loading doses of antiplatelet medication prior to the procedure.On the same day post index procedure, the subject was found to have gone into a cardiogenic shock diagnosed by x ray, diagnostic catheterization and lab tests.At the time of reporting, the event was considered to be recovering.It was further reported that normal sinus rhythm was noted post valve deployment.The patient was pulseless with loss of blood pressure for 15 minutes.The previously reported coronary angiogram also detected a spastic lad artery.Myocardial infarction occurred.Despite many attempts during recanalization and aspiration, it was not possible to remove the thrombus from the lcx and the main stem.The previously reported stents were a 4.0x18mm non-boston scientific (bsc) des was implanted in the lcx towards the main stem and a 3.0x28mm non-bsc des and a 3.5x23mm non-bsc des were implanted into the lad up to the ostium using the tap technique.The previously reported capillary leak syndrome was due to prolonged resuscitation.A total of 4 units of platelets, 2 units of fresh frozen plasma (ffp) and 10 units of packed red blood cells (prbc) were transfused.

• 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: 10904704
• MDR Text Key: 218269419
• Report Number: 2134265-2020-15570
• 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,foreig
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/19/2021

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 Expiration Date: 12/04/2020
• Device Model Number: 10394
• Device Catalogue Number: 10394
• Device Lot Number: 0026077945
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 11/24/2020; 12/16/2020; 01/25/2021
• Supplement Dates FDA Received: 12/11/2020; 01/04/2021; 02/19/2021
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 82 YR