UNKVISTABRITEE
Report
- Report Number
- 9616099-2019-02910
- Event Type
- Injury
- Date Received
- May 8, 2019
- Date of Event
- June 13, 2017
- Report Date
- May 8, 2019
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DQY
- PMA / PMN Number
- K971572
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE DEVICE IS AN 8F VISTA BRITE TIP GUIDING CATHETER BUT THE CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS; MAUS, V., YOU, S., KALKAN, A., BORGGREFE, J., KABBASCH, C., BARNIKOL, U. B., MPOTSARIS, A. (2017). INCOMPLETE LARGE VESSEL OCCLUSIONS IN MECHANICAL THROMBECTOMY: AN INDEPENDENT PREDICTOR OF FAVORABLE OUTCOME IN ISCHEMIC STROKE. CEREBROVASCULAR DISEASES, 44(3-4), 113-121. AS REPORTED IN LITERATURE BY MAUS, V., YOU, S., KALKAN, A., BORGGREFE, J., KABBASCH, C., BARNIKOL, U. B., MPOTSARIS, A. (2017). INCOMPLETE LARGE VESSEL OCCLUSIONS IN MECHANICAL THROMBECTOMY: AN INDEPENDENT PREDICTOR OF FAVORABLE OUTCOME IN ISCHEMIC STROKE. CEREBROVASCULAR DISEASES, 44(3-4), 113-121. DOI:10.1159/000477499; REPORT ONE CASE OF VASOSPASM OF THE INTERNAL CAROTID DURING A MECHANICAL THROMBECTOMY USING AN 8F VISTA BRITE TIP GUIDING CATHETER. THE VASOSPASM WAS SUCCESSFULLY COUNTERACTED WITH INTRA-ARTERIAL NIMODIPINE. THE PATIENT WAS A (B)(6) THAT HAD SUFFERED FROM AN ACUTE LEFT-SIDED HEMIPARESIS AND DIPLOPIA WITH A NATIONAL INSTITUTES OF HEALTH STROKE SCALE OF 16 ON ADMISSION. CT ANGIOGRAPHY PERFORMED 60 MIN AFTER SYMPTOM ONSET SHOWED AN INCOMPLETE LVO OF THE RIGHT M1. AFTER INTRAVENOUS THROMBOLYSIS, THE PATIENT WAS TRANSFERRED TO THE ANGIO SUITE AND DIGITAL SUBTRACTION ANGIOGRAPHY CONFIRMED THE INCOMPLETE OCCLUSION (C). AFTER A SINGLE MECHANICAL THROMBECTOMY MANEUVER WITH A STENT RETRIEVER AND DISTAL ASPIRATION, RECANALIZATION WAS SUCCESSFUL WITH COMPLETE REPERFUSION, MTICI 3 (D). MT WAS PERFORMED FOR MIDDLE CEREBRAL ARTERY STROKE BY USING THE ONE-THIRD RULE [12] . WITH GROWING EXPERIENCE AND SUBSEQUENT RESEARCH, A WIDER RANGE OF IMAGING AND CLINICAL-BASED INDICATIONS WERE EXECUTED STEPWISE. THESE WERE AS FOLLOWS: ARTERIAL OCCLUSION IN CERVICAL AND/OR CEREBRAL ARTERIES ON CT OR MAGNET RESONANCE IMAGING ANGIOGRAPHY (CTA/MRA) IN RELATION TO THE ISCHEMIC TERRITORY; NO AGE LIMIT AND BASELINE NIHSS SCORE OF = 5 OR APHASIA. PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA. DIFFERENT TECHNIQUES OF MT WERE EXECUTED OVER TIME. BASED ON A TRI-AXIAL APPROACH WITH AN 8 FR GUIDING CATHETER (VISTA BRITE TIP ® , JOHNSON & JOHNSON, NEW BRUNSWICK, NJ, USA) IN THE INTERNAL CAROTID ARTERY/6 FR GUIDING CATHETER (ENVOY ® , CORDIS, FREMONT, CA, USA) IN THE VA, STENT RETRIEVERS WERE USED FROM THE BEGINNING IN COMBINATION WITH AN ASPIRATION CATHETER ¿ A DISTAL ACCESS CATHETER (CONCENTRIC, MOUNTAIN VIEW, CA, USA), A NAVIEN TM CATHETER (COVIDIEN, DUBLIN, IRELAND), OR LATER A SOFIA ® CATHETER (MICROVENTION, TUSTIN, CA, USA), WHICH WAS PLACED DISTALLY IN THE INTERNAL CAROTID ARTERY OR VA. THE STENT RETRIEVER WAS THEN WITHDRAWN INTO THE ASPIRATION CATHETER DURING LOCAL ASPIRATION [13, 14]. THESE STEPS WERE REPEATED UNTIL THE FINAL REPERFUSION RESULT WAS REACHED; THE MAXIMUM NUMBER OF ATTEMPTS WAS UP TO THE OPERATOR AND DID NOT EXCEED 10 IN ANY CASE IN THESE SERIES. PREDOMINANTLY, THE TREVO ® XP PROVUE RETRIEVER (STRYKER, FREMONT, CA, USA) AND THE SOLITAIRE TM AB/FR REVASCULARIZATION DEVICES (MEDTRONIC, MINNEAPOLIS, MN, USA) WERE USED IN >90% OF THE PROCEDURES; SINCE 2014, THE EMBOTRAP ® REVASCULARIZATION DEVICE (NEURAVI, GALWAY, IRELAND) WAS EMPLOYED AS WELL. WITH ONGOING RESEARCH, WE INTRODUCED THE FIRSTLINE, DIRECT-ASPIRATION FIRST-PASS TECHNIQUE (ADAPT) PREDOMINANTLY PERFORMED WITH A SOFIA ® CATHETER AS A LARGE-BORE ASPIRATION CATHETER IN 2014 [15¿17] . INTRAPROCEDURAL USE AND CHOICE OF STENT RETRIEVER(S) AND/OR ASPIRATION CATHETER WAS LEFT TO THE ATTENDING PHYSICIAN¿S DISCRETION. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING RECORDS COULD NOT BE CONDUCTED WITHOUT A LOT NUMBER. VESSEL SPASM IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH ANY INTERVENTIONAL PROCEDURE WHERE DEVICES ARE INTRODUCED INTO THE VASCULATURE AND IS LISTED IN THE IFU (INSTRUCTIONS FOR USE) AS SUCH. LOCAL VASOSPASM CAN BE CAUSED BY THE DEVICE MANIPULATIONS INHERENT IN ANY PROCEDURE CAUSING ENDOTHELIAL IRRITATION. A CAROTID VESSEL SPASM IS A BRIEF TEMPORARY TIGHTENING OF THE MUSCLES IN THE VESSEL WALL. THIS CAN NARROW AND BRIEFLY DECREASE OR EVEN PREVENT BLOOD FLOW TO THE BRAIN. THIS MAY LEAD TO TIA SYMPTOMS SUCH AS REFLEX CHANGE. TREATMENT OF ARTERIAL SPASMS MAY INCLUDE MEDICATIONS SUCH AS NITRATES AND CALCIUM CHANNEL BLOCKERS. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS AND WITHOUT FILMS OF THE EVENT, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.
AS REPORTED IN LITERATURE BY MAUS, V., YOU, S., KALKAN, A., BORGGREFE, J., KABBASCH, C., BARNIKOL, U. B., MPOTSARIS, A. (2017). INCOMPLETE LARGE VESSEL OCCLUSIONS IN MECHANICAL THROMBECTOMY: AN INDEPENDENT PREDICTOR OF FAVORABLE OUTCOME IN ISCHEMIC STROKE. CEREBROVASCULAR DISEASES, 44(3-4), 113-121. DOI:10.1159/000477499; REPORT ONE CASE OF VASOSPASM OF THE INTERNAL CAROTID DURING A MECHANICAL THROMBECTOMY USING AN 8F VISTA BRITE TIP GUIDING CATHETER. THE VASOSPASM WAS SUCCESSFULLY COUNTERACTED WITH INTRA-ARTERIAL NIMODIPINE. THE PATIENT WAS A (B)(6) THAT HAD SUFFERED FROM AN ACUTE LEFT-SIDED HEMIPARESIS AND DIPLOPIA WITH A NATIONAL INSTITUTES OF HEALTH STROKE SCALE OF 16 ON ADMISSION. CT ANGIOGRAPHY PERFORMED 60 MIN AFTER SYMPTOM ONSET SHOWED AN INCOMPLETE LVO OF THE RIGHT M1. AFTER INTRAVENOUS THROMBOLYSIS, THE PATIENT WAS TRANSFERRED TO THE ANGIO SUITE AND DIGITAL SUBTRACTION ANGIOGRAPHY CONFIRMED THE INCOMPLETE OCCLUSION (C). AFTER A SINGLE MECHANICAL THROMBECTOMY MANEUVER WITH A STENT RETRIEVER AND DISTAL ASPIRATION, RECANALIZATION WAS SUCCESSFUL WITH COMPLETE REPERFUSION, MTICI 3 (D). MT WAS PERFORMED FOR MIDDLE CEREBRAL ARTERY STROKE BY USING THE ONE-THIRD RULE [12] . WITH GROWING EXPERIENCE AND SUBSEQUENT RESEARCH, A WIDER RANGE OF IMAGING AND CLINICAL-BASED INDICATIONS WERE EXECUTED STEPWISE. THESE WERE AS FOLLOWS: ARTERIAL OCCLUSION IN CERVICAL AND/OR CEREBRAL ARTERIES ON CT OR MAGNET RESONANCE IMAGING ANGIOGRAPHY (CTA/MRA) IN RELATION TO THE ISCHEMIC TERRITORY; NO AGE LIMIT AND BASELINE NIHSS SCORE OF = 5 OR APHASIA. PROCEDURES WERE PERFORMED UNDER GENERAL ANESTHESIA. DIFFERENT TECHNIQUES OF MT WERE EXECUTED OVER TIME. BASED ON A TRI-AXIAL APPROACH WITH AN 8 FR GUIDING CATHETER (VISTA BRITE TIP ® , JOHNSON & JOHNSON, NEW BRUNSWICK, NJ, USA) IN THE INTERNAL CAROTID ARTERY/6 FR GUIDING CATHETER (ENVOY ® , CORDIS, FREMONT, CA, USA) IN THE VA, STENT RETRIEVERS WERE USED FROM THE BEGINNING IN COMBINATION WITH AN ASPIRATION CATHETER ¿ A DISTAL ACCESS CATHETER (CONCENTRIC, MOUNTAIN VIEW, CA, USA), A NAVIEN TM CATHETER (COVIDIEN, DUBLIN, IRELAND), OR LATER A SOFIA ® CATHETER (MICROVENTION, TUSTIN, CA, USA), WHICH WAS PLACED DISTALLY IN THE INTERNAL CAROTID ARTERY OR VA. THE STENT RETRIEVER WAS THEN WITHDRAWN INTO THE ASPIRATION CATHETER DURING LOCAL ASPIRATION [13, 14]. THESE STEPS WERE REPEATED UNTIL THE FINAL REPERFUSION RESULT WAS REACHED; THE MAXIMUM NUMBER OF ATTEMPTS WAS UP TO THE OPERATOR AND DID NOT EXCEED 10 IN ANY CASE IN THESE SERIES. PREDOMINANTLY, THE TREVO ® XP PROVUE RETRIEVER (STRYKER, FREMONT, CA, USA) AND THE SOLITAIRE TM AB/FR REVASCULARIZATION DEVICES (MEDTRONIC, MINNEAPOLIS, MN, USA) WERE USED IN >90% OF THE PROCEDURES; SINCE 2014, THE EMBOTRAP ® REVASCULARIZATION DEVICE (NEURAVI, GALWAY, IRELAND) WAS EMPLOYED AS WELL. WITH ONGOING RESEARCH, WE INTRODUCED THE FIRSTLINE, DIRECT-ASPIRATION FIRST-PASS TECHNIQUE (ADAPT) PREDOMINANTLY PERFORMED WITH A SOFIA ® CATHETER AS A LARGE-BORE ASPIRATION CATHETER IN 2014 [15¿17] . INTRAPROCEDURAL USE AND CHOICE OF STENT RETRIEVER(S) AND/OR ASPIRATION CATHETER WAS LEFT TO THE ATTENDING PHYSICIAN¿S DISCRETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 383979 | UNKVISTABRITEE | GUIDING CATHETER | DQY | CORDIS CORPORATION | N/A | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Life Threatening| R |