PARADISE ULTRASOUND RENAL DENERVATION SYSTEM
Report
- Report Number
- 3010024164-2024-00009
- Event Type
- Injury
- Date Received
- November 21, 2024
- Date of Event
- December 5, 2023
- Report Date
- November 21, 2024
- Manufacturer
- RECOR MEDICAL, INC.
- Product Code
- QYI
- PMA / PMN Number
- P220023
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
THE EVENT WAS INITIALLY REPORTED ON (B)(6) 2023 AS "POST-PRECEDURAL THORACIC PRESSURE" WITH NO INTERVENTION NEEDED. HOWEVER, ON (B)(6) 2024, SITE UPDATED THE EVENT TERM FROM "POST-PRECEDURAL THORACIC PRESSURE" TO "SYNCOPE" AND UPDATED THE EVENT DESCRIPTION FROM NO ACTION TAKEN TO REANIMATION AS AN INTERVENTION. THE EVENT WAS REASSESSED AND WAS CONSIDERED REPORTABLE BASED ON THE NEW INFORMATION. NOTE: PATIENT IDENTIFIER FIELD HAS LIMITED CHARACTER SETTING AND THE FORM FIELD WOULD NOT ALLOW TO ENTER THE COMPLETE PATIENT IDENTIFIER INFORMATION. ADDING THE PATIENT IDENTIFIER HERE AS REFERENCE - PATIENT IDENTIFIER: (B)(6).
NO CORRELATION OF THE EVENT WITH DEVICE WAS FOUND. THERE IS NO INDICATION OF ANY FAILURE OF THE DEVICE. IN ADDITION, THERE IS NO INDICATION OF ANY MISUSE OF THE DEVICE. EVENT: SYNCOPE VASOVAGAL. 60-YEAR-OLD MALE ENROLLED IN THE GPS REGISTRY ON (B)(6) 2023. PAST MEDICAL HISTORY WAS SIGNIFICANT FOR HYPERTENSION SINCE 2012 (LAST EPISODE OF HYPERTENSIVE CRISIS ON (B)(6) 2023), HYPERLIPIDEMIA, RECENT EPISODE OF ANGINA IN (B)(6) 2022, 3 -VESSEL CORONARY ARTERY DISEASE WITH 5 STENT REVASCULARIZATION PROCEDURES. SUBJECT WAS ON 5 ANTI-HTN MEDICATIONS (RAMIPRIL 10MG, LERCANIDIPINE 20MG, HYDROCHLOROTHIAZIDE 25MG, METOPROLOL 95MG, MOXINIDIN 0.4MG) AT THE TIME OF CONSENT. ON (B)(6) 2023, THE SUBJECT UNDERWENT RENAL DENERVATION PROCEDURE, AND THE PROCEDURE WAS UNEVENTFUL. AFTER THE PROCEDURE, THE SUBJECT EXPERIENCED SYNCOPE ASSOCIATED WITH A DROP IN BLOOD PRESSURE. BRIEF RESUSCITATION FOR APPROXIMATELY ONE MINUTE WAS PERFORMED, AFTER WHICH SPONTANEOUS CIRCULATION RESUMED. AN EMERGENCY CORONARY ANGIOGRAPHY WAS PERFORMED WHICH NOTED STABLE FINDINGS WITHOUT ANY PROGRESSION OF THREE-VESSEL CORONARY ARTERY DISEASE, AND NO INTERVENTION WAS REQUIRED. A CT SCAN WAS ALSO PERFORMED, WHICH RULED OUT BOTH AORTIC DISSECTION AND PULMONARY EMBOLISM. ADDITIONALLY, A 24-HOUR LONG-TERM ECG SHOWED BASIC SINUS RHYTHM, RATE 47 TO 92/MIN (AVERAGE 55/MIN) AND OCCASIONAL VENTRICULAR AND ATRIAL EXTRASYSTOLES. ON (B)(6) 2023, TRANSTHORACIC ECHOCARDIOGRAPHY REVEALED A NORMAL BIVENTRICULAR PUMPING FUNCTION WITHOUT ANY EVIDENCE OF HEART VALVE DEFECTS. ON THE SAME DAY, A TILT TABLE TEST WAS PERFORMED, DURING WHICH THE SUBJECT EXPERIENCED PRESYNCOPE WITH HYPOTENSION, NAUSEA, PALLOR AND WAS DIAGNOSED WITH NEUROCARDIAL DYSREGULATION TYPE I. AS PER HOSPITAL NOTES, THIS EPISODE OF SYNCOPE IS MOST LIKELY VASOVAGAL, ATTRIBUTED TO THE APPLICATION OF PRESSURE BANDAGE. NO CHANGES TO ANTI-HYPERTENSIVE MEDICATIONS WERE RECOMMENDED HOWEVER LONG-TERM ORAL ANTICOAGULATION WITH RIVAROXABAN 20MG WAS STARTED ON A BACKGROUND OF ATRIAL FIBRILLATION. THE EVENT WAS RESOLVED ON (B)(6) 2023 AND THE SUBJECT WAS DISCHARGED FROM HOSPITAL THE SAME DAY. NOTE: THE EVENT WAS INITIALLY REPORTED ON (B)(6) 2023 AS "POST-PRECEDURAL THORACIC PRESSURE" WITH NO INTERVENTION NEEDED. HOWEVER, ON (B)(6) 2024, SITE UPDATED THE EVENT TERM FROM "POST-PRECEDURAL THORACIC PRESSURE" TO "SYNCOPE" AND UPDATED THE EVENT DESCRIPTION FROM NO ACTION TAKEN TO REANIMATION AS AN INTERVENTION. THE EVENT WAS REASSESSED AND WAS CONSIDERED REPORTABLE BASED ON THE NEW INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2580012 | PARADISE ULTRASOUND RENAL DENERVATION SYSTEM | ABLATION CATHETER RENAL DENERVATION | QYI | RECOR MEDICAL, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Male | Hospitalization| R | ASPIRIN| BISOPROLOL| HYDROCHLOROTHIAZIDE| LERCANIDIPIN| METOPROLOL| MOXONIDIN| RAMIPRIL| RANOLAZINE| RIVAROXABAN |