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 Syncope (1610); Arrhythmia (1721); Chest Pain (1776); Complete Heart Block (2627)

Event Date 08/07/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

(b)(6) study.It was reported that complete heart block (chb) occurred.The patient was enrolled into the (b)(6) study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was not given and the patient was on prior regimen of aspirin.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 25 mm lotus edge valve.Four days post index procedure, the patient developed chb.X-ray and lab tests were performed as diagnostic tests.The patient was hospitalized, medication was adjusted, and a new permanent pacemaker was implanted.That day, the event was considered resolved.Six days post the index procedure, the patient was discharged on aspirin.

Manufacturer Narrative

A1 patient id (b)(6).E1 initial reporter phone number: (b)(6).

Event Description

Respond edge study.It was reported that complete heart block (chb), chest pain and syncope occurred.The patient was enrolled into the respond edge study and the index procedure was performed on the same day.Prior to the index procedure, heparin or other anticoagulant was not given and the patient was on prior regimen of aspirin.A lotus introducer was placed and the aortic valve was treated with balloon valvuloplasty and subsequent deployment of a 25 mm lotus edge valve.Four days post index procedure, the patient developed chb.X-ray and lab tests were performed as diagnostic tests.The patient was hospitalized, medication was adjusted, and a new permanent pacemaker was implanted.That day, the event was considered resolved.Six days post the index procedure, the patient was discharged on aspirin.It was further reported that the patient was discharged one day post index procedure on rivaroxaban.Four days post index procedure, the patient presented with complaints of chest pain, dizziness and syncope.Electrocardiogram revealed left bundle branch block (lbbb).It was then that the patient was diagnosed with chb and had 10 second pauses.The patient was hospitalized, atropine and isoprenaline infusion were given, and the permanent pacemaker was implanted.Six days post index procedure, an electrocardiogram revealed normal sinus rhythm with lbbb.The patient was noted to have made a steady recovery and was considered medically ready for discharge.That day, the patient discharged on aspirin and other anticoagulant.At the patient's six week follow-up with the cardiologist, the patient's condition had gradually improved.The patient mobilized around the house without any significant complaints of chest discomfort or shortness of breath.However, occasional episodes of dizziness were still noted which was presumed to resolve in the following weeks.Aspirin was recommended to be continued and rivaroxaban was withheld.

• 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: 10420531
• MDR Text Key: 203326657
• Report Number: 2134265-2020-11242
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 10/02/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2020
• Device Model Number: 10394
• Device Catalogue Number: 10394
• Device Lot Number: 0025675175
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 09/15/2020
• Supplement Dates FDA Received: 10/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 90 YR