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

Model Number 10394

Device Problem Degraded (1153)

Patient Problems Aortic Insufficiency (1715); Thrombosis (2100)

Event Date 01/01/2020

Event Type  Injury  

Event Description

It was reported that valve thrombosis occurred.Procedure summary: a 27mm lotus edge valve was successfully implanted in (b)(6) 2019 with a final gradient of 16 mmhg and activated clotting time of 200-250 seconds.The patient was stable post procedure.The patient was started on anticoagulant marcumar.Post procedure event summary: in the year following the (b)(6) 2019 implant, increased aortic gradient elevation was observed at three routine follow up examinations.The aortic gradient increased from 16mhg to 31mmhg to 42mmhg.A positron emission tomography computed tomography (pet ct) scan was performed and thrombotic formations were noted.The patient's international normalized ratio (inr) blood level was noted to be 2.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 10908407
• MDR Text Key: 218516901
• Report Number: 2134265-2020-15843
• Device Sequence Number: 1
• Product Code: NPT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P180029
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2020
• Device Model Number: 10394
• Device Catalogue Number: 10394
• Device Lot Number: 0023810356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/17/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Removal/Correction Number: 92630745-FA
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR