APOLLO
Report
- Report Number
- 2029214-2023-01346
- Event Type
- Injury
- Date Received
- August 9, 2023
- Date of Event
- December 23, 2017
- Report Date
- August 9, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
EVENT RELATED TO REGULATORY REPORT: 2029214-2023-01345 MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
T. R. MILLER, L. GIACON, M. J. KOLE, R. CHEN, G. JINDAL, AND D. GANDHI; INTERVENTIONAL NEURORADIOLOGY; 2018; 0(00) 1¿6; ONYX EMBOLIZATION WITH THE APOLLO DETACHABLE TIP MICROCATHETER: A SINGLE-CENTER EXPERIENCE; DOI: 10.1177/1591019918758494. MEDTRONIC RECEIVED INFORMATION IN A LITERATURE ARTICLE THAT PATIENTS TREATED WITH APOLLO CATHETERS AND ONYX EMBOLIZATION HAD COMPLICATIONS. THE PURPOSE OF THE ARTICLE WAS TO REPORT THE AUTHORS' EXPERIENCE WITH THE APOLLO CATHETER IN A VARIETY OF NEUROINTERVENTIONAL PROCEDURES. THEY RETROSPECTIVELY REVIEWED ALL ONYX EMBOLIZATIONS PERFORMED IN THE HEAD, NECK, AND SPINE USING THE APOLLO ONYX DELIVERY MICROCATHETER FROM ITS INTRODUCTION AT THEIR INSTITUTION IN JULY 2014 TO AUGUST 2016. A TOTAL OF 58 ARTERIAL PEDICLE ONYX EMBOLIZATIONS WERE PERFORMED IN 37 PATIENTS. IN THE MAJORITY OF PEDICLE EMBOLIZATIONS, A 30 MM DETACHABLE-TIP APOLLO WAS UTILIZED (43; 74%). SEVEN PATIENTS UNDERWENT MORE THAN ONE ONYX EMBOLIZATION PROCEDURE USING APOLLO DURING THE STUDY PERIOD (RANGE 2¿3), WHILE TWO PEDICLE EMBOLIZATIONS WERE PERFORMED IN THE SAME PROCEDURE IN 10 INSTANCES (AVERAGE 1.17 PEDICLE EMBOLIZATIONS PER PROCEDURE IN THE COHORT). A DUAL-MICROCATHETER TECHNIQUE WAS UTILIZED IN SEVEN PEDICLE EMBOLIZATIONS. PROCEDURE: ALL PROCEDURES WERE PERFORMED BY ONE OF THREE NEUROINTERVENTIONAL RADIOLOGISTS UNDER GENERAL ENDOTRACHEAL ANESTHESIA. WHILE SOME PROCEDURES WERE PERFORMED USING A SHORT 6F SHEATH PLACED IN THE COMMON FEMORAL ARTERY AND A 6F GUIDE CATHETER, OTHERS WITH TORTUOUS PARENT ANATOMY EMPLOYED A 6F SHUTTLE SHEATH AND A DISTAL ACCESS CATHETER, SUCH AS A 058 NAVIEN. THE APOLLO MICROCATHETER WAS ADVANCED OVER A 0.010- OR 0.008-INCH MICROWIRE AND INTO THE DISTAL TARGET PEDICLE USING THE BIPLANE ROADMAP TECHNIQUE. ONYX EMBOLIZATION WAS THEN PERFORMED THROUGH THE MICROCATHETER UTILIZING EITHER ONYX 18, 34, OR A COMBINATION OF BOTH, DEPENDING ON THE LESION AND ARTERIAL PEDICLE UTILIZED. IN A SUBSET OF PEDICLE EMBOLIZATIONS, A SECOND, NON-DETACHABLE MICROCATHETER WAS INITIALLY UTILIZED TO FORM A ¿¿PLUG¿¿ OF LIQUID EMBOLIC MATERIAL AROUND THE SLIGHTLY MORE DISTALLY POSITIONED APOLLO MICROCATHETER. THE PROXIMAL MICROCATHETER WAS REMOVED AFTER FORMATION OF THE PLUG, FOLLOWED BY THE PRIMARY EMBOLIZATION PERFORMED VIA APOLLO. THIS DUAL-MICROCATHETER TECHNIQUE WAS UTILIZED TO PROMOTE BETTER FORWARD PENETRATION OF THE LIQUID EMBOLIC AGENT BY THE EARLY FORMATION OF A ROBUST PROXIMAL PLUG OF MATERIAL AROUND THE APOLLO MICROCATHETER. AFTER THE DESIRABLE EMBOLIZATION WAS ACHIEVED, TENSION WAS GENTLY APPLIED TO THE APOLLO MICROCATHETER UNTIL THE DEVICE EITHER RELEASED FROM THE LIQUID EMBOLIC CAST OR TIP DETACHMENT OCCURRED. ANGIOGRAPHY WAS PERFORM ED FOLLOWING MICROCATHETER WITHDRAWAL TO ASSESS THE RESULTS OF EMBOLIZATION AS WELL AS TO IDENTIFY ANY COMPLICATIONS. FOR VASCULAR MALFORMATIONS NOT UNDERGOING SUBSEQUENT SURGICAL OR STEREOTACTIC RADIO-SURGERY TREATMENT, FOLLOW-UP ANGIOGRAPHY, AND/OR REPEAT EMBOLI ZATION WAS TYPICALLY PERFORMED WITHIN THREE TO SIX MONTHS, DEPENDING ON THE RESULTS OF THE FIRST SESSION. FOLLOW-UP IMAGING WAS TYPICALLY NOT PERFORMED FOR OTHER INDICATIONS. RESULTS: THE APOLLO MICROCATHETER WAS SUCCESSFULLY NAVIGATED INTO THE TARGET PEDICLE IN 57 OF 58 PEDICLE CATHETERIZATIONS (98%). IN THE REMAINING INSTANCE, THE APOLLO MICROCATHETER COULD NOT BE NAVIGATED TO A POSITION WHERE LIQUID EMBOLIZATION COULD SAFELY BE PERFORMED FOR TREATMENT OF A CRANIAL DURAL ARTERIOVENOUS FISTULAS (DAVFS) DUE TO PEDICLE TORTUOSITY. THERE WERE NO TECHNICAL COMPLICATIONS ASSOCIATED WITH THE USE OF APOLLO IN THIS INSTANCE, AND THE CASE WAS SUBSEQUENTLY EXCLUDED FROM FURTHER ANALYSIS. THE DISTAL MICROCATHETER TIP DETACHED IN THE LIQUID EMBOLIC CAST UPON DEVICE REMOVAL IN 42 INSTANCES (73.7%). THERE WERE NO CASES OF MICROCATHETER ENTRAPMENT, EARLY/INADVERTENT TIP DETACHMENT, OR PEDICLE INJURY UPON REMOVAL OF THE MICROCATHETER. HOWEVER, THERE WERE TWO INSTANCES OF A SMALL AMOUNT OF LEAKAGE OF LIQUID EMBOLIC AGENT FROM THE MICROCATHETER DETACHMENT SITE (3.5%) DURING EMBOLIZATION. ONE OCCURRED DURING TREATMENT OF A SPINAL DAVF VIA AN AORTIC SEGMENTAL ARTERY, WHILE THE OTHER INVOLVED TREATMENT OF AN INTRACRANIAL DAVF VIA A MIDDLE MENINGEAL ARTERY PEDICLE. IN BOTH INSTANCES, THE LEAKAGE WAS PROMPTLY DETECTED AND THE DETACHMENT ZONE WAS LOCATED WELL WITHIN THE TARGET PEDICLE. CONSEQUENTLY, NEITHER EVENT RESULTED IN NON-TARGET EMBOLIZATION OR CLINICAL SEQUELAE. HOWEVER, THE SPINAL DAVF HAD TO BE SUBSEQUENTLY TREATED WITH MICROSURGICAL REPAIR BECAUSE OF EARLY TERMINATION OF ONYX EMBOLIZATION. IN THE CASE OF THE DAVF, THE LESION WAS SUCCESSFULLY OBLITERATED BY EMBOLIZATION PERFORMED VIA THE CONTRALATERAL MIDDLE MENINGEAL ARTERY. CLINICAL OUTCOMES IN THE COHORT WERE OVERALL EXCELLENT. IN 18 PATIENTS TREATED FOR CRANIAL DAVF, ALL BUT TWO WERE SUCCESSFULLY CURED BY ENDOVASCULAR THERAPY ALONE. FIVE REQUIRED MORE THAN ONE ENDOVASCULAR TREATMENT PROCEDURE (RANGE 1¿3). OF THE REMAINING TWO PATIENTS, ONE WAS SUCCESSFULLY TREATED BY A COMBINED ENDOVASCULAR AND SURGICAL APPROACH, WHILE THE OTHER HAD A SMALL RESIDUAL FISTULA AT THE END OF THE PROCEDURE AND WAS SUBSEQUENTLY LOST TO FOLLOW-UP. IN 10 PATIENTS TREATED FOR CEREBRAL AVMS AND/OR FLOW-RELATED ANEURYSMS, ALL PROCEDURES ACHIEVED THEIR CLINICAL GOAL. IN FIVE PROCEDURES, A TARGET ANEURYSM WAS CLOSED, WHILE THERE WAS A SIGNIFICANT REDUCTION IN SIZE OF THE AVM NIDUS IN THE REMAINING FIVE PATIENTS, WHO WERE SUBSEQUENTLY TREATED EITHER BY STEREOTACTIC RADIOSURGERY OR SURGICAL RESECTION. OVERALL, THERE WERE NO INSTANCES OF PROCEDURE-RELATED PERMANENT NEUROLOGIC DISABILITY OR MORTALITY IN THE COHORT. ONE PATIENT TREATED FOR A CRANIAL DAVF HAD A VENOUS INFARCT WITH ASSOCIATED INTRAPARENCHYMAL HEMORRHAGE THE DAY FOLLOWING THE PROCEDURE DUE TO PROGRESSIVE THROMBOSIS IN A LARGE, VENOUS VARIX. THE PATIENT EXPERIENCED TEMPORARY CONTRALATERAL ARM AND LEG WEAKNESS AS WELL AS NEGLECT, WHICH SUBSEQUENTLY COMPLETELY RESOLVED. THE PATIENT LATER UNDERWENT A SUCCESSFUL SECOND EMBOLIZATION FOR RECURRENCE OF THE SAME FISTULA WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1588482 | APOLLO | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | UNK-NV-APOLLO | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |