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

Model Number 10418

Device Problems Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Perforation of Vessels (2135)

Event Date 08/13/2020

Event Type  malfunction  

Event Description

(b)(6) study.It was reported that entanglement with the pigtail catheter and arrhythmia occurred.The subject was enrolled into (b)(6) 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 at the time.A loading dose of 75 mg of clopidogrel was given on the day of the index procedure.Vascular access was obtained via a right transfemoral approach.The patient had protruding calcium in the left ventricular outflow tract (lvot) and a lovt at 23.5mm.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty (bav).No new conduction disturbance was noted post bav.A 27mm lotus edge valve (lot#0025020096) was inserted.During positioning, the 27 mm lotus edge valve had popped up.The 27mm lotus edge valve was resheathed for repositioning.The physician elected not to move the 5f al1 pigtail catheter upward during resheathing as it had been difficult to originally get the pigtail in the non coronary cusp (ncc).During re-sheathing, the 5f al1 pigtail catheter was folded over and became entangled in the 27mm lotus edge valve delivery system.Multiple attempts were made to dislodge the 5f al1pigtail catheter including re-deployment of the 27mm lotus edge valve, push and pull maneuvers, and insertion of guidewires.All maneuvers were unsuccessful.The 5f fl1 pigtail was cut at the hub.The cut end was pulled into the subject's body and removed together with the 27mm lotus edge valve system through the 27mm lotus edge valve system access site.Both devices were removed by simply withdrawing the devices through the lotus introducer sheath with no difficulty or resistance felt when removing the devices.The 27mm lotus edge valve (lot#0025020096) was exchanged for a new 27 mm lotus edge valve (lot# 0025020097) which was inserted and deployed.Successful repositioning of the 27mm lotus edge valve (lot# 0025020097) involved complete and partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).During the index procedure, the patient developed left bundle branch block (lbbb), 1st and 2nd degree atrioventricular (av) block, type ii.Hospitalization was prolonged and a permanent pacemaker was recommended.On the same day, echocardiogram revealed a torn chordae and mobile echodensity in the proximal descending thoracic aorta/distal aortic arch consistent with intimal disruption.The torn chordae was attributed to poor wire management of the safari2 guide wire.Four (4) days post index procedure, a permanent pacemaker was successfully implanted.Five (5) days post index procedure, the patient was discharged on aspirin.

Manufacturer Narrative

H3 device evaluated by mfr: a 27mm lotus edge device was returned for analysis.The device returned partially sheathed with a blue pigtail protruding from the tip of the outer sheath.A compression was noted to the outer sheath from 3.2cm proximal from the distal tip of the outer sheath extending proximally for 13.5cm.The multi- lumen extrusion port was flushed with 15mls of saline and the device was unsheathed without issue.The section of pigtail was removed distally from the device without issue.The valve was locked and released without issue.No other issues were noted with the device.

Event Description

Reprise iv study.It was reported that entanglement with the pigtail catheter and arrhythmia occurred.The subject 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 at the time.A loading dose of 75 mg of clopidogrel was given on the day of the index procedure.Vascular access was obtained via a right transfemoral approach.The patient had protruding calcium in the left ventricular outflow tract (lvot) and a lovt at 23.5mm.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty (bav).No new conduction disturbance was noted post bav.A 27mm lotus edge valve (lot#0025020096) was inserted.During positioning, the 27 mm lotus edge valve had popped up.The 27mm lotus edge valve was resheathed for repositioning.The physician elected not to move the 5f al1 pigtail catheter upward during resheathing as it had been difficult to originally get the pigtail in the non coronary cusp (ncc).During re-sheathing, the 5f al1 pigtail catheter was folded over and became entangled in the 27mm lotus edge valve delivery system.Multiple attempts were made to dislodge the 5f al1pigtail catheter including re-deployment of the 27mm lotus edge valve, push and pull maneuvers, and insertion of guidewires.All maneuvers were unsuccessful.The 5f fl1 pigtail was cut at the hub.The cut end was pulled into the subject's body and removed together with the 27mm lotus edge valve system through the 27mm lotus edge valve system access site.Both devices were removed by simply withdrawing the devices through the lotus introducer sheath with no difficulty or resistance felt when removing the devices.The 27mm lotus edge valve (lot#0025020096) was exchanged for a new 27 mm lotus edge valve (lot# 0025020097) which was inserted and deployed.Successful repositioning of the 27mm lotus edge valve (lot# 0025020097) involved complete and partial re-sheathing and deployment into a more accurate position within the aortic annulus, in accordance with the instructions for use (ifu).During the index procedure, the patient developed left bundle branch block (lbbb), 1st and 2nd degree atrioventricular (av) block, type ii.Hospitalization was prolonged and a permanent pacemaker was recommended.On the same day, echocardiogram revealed a torn chordae and mobile echodensity in the proximal descending thoracic aorta/distal aortic arch consistent with intimal disruption.The torn chordae was attributed to poor wire management of the safari2 guide wire.Four (4) days post index procedure, a permanent pacemaker was successfully implanted.Five (5) days post index procedure, the patient was discharged on aspirin.It was further reported that on the same day post index procedure, the subject developed 2nd degree av block, weinkebach type.Four (4) days post index procedure, electrocardiogram was unremarkable except sinus or ectopic atrial rhythm.During the permanent pacemaker implant, subject became hypotensive and developed complete heart block along with asystole.The subject's blood pressure trended down gradually.

• 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: 10474579
• MDR Text Key: 205089919
• Report Number: 2134265-2020-11682
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2020
• Device Model Number: 10418
• Device Catalogue Number: 10418
• Device Lot Number: 0025020096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 09/04/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 75