APOLLO
Report
- Report Number
- 2029214-2020-01012
- Event Type
- Injury
- Date Received
- October 11, 2020
- Date of Event
- October 6, 2020
- Report Date
- September 19, 2021
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- PMA / PMN Number
- P030004/S006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- PHYSICIAN
Narratives
H3: AN APOLLO MICRO CATHETER AND 4 ONYX VIALS WERE RETURNED FOR ANALYSIS. THE APOLLO MICRO CATHETER WAS RETURNED WITH A SYRINGE FILLED WITH ~5ML OF ONYX ATTACHED TO THE APOLLO HUB. THE APOLLO MICRO CATHETER TOTAL LENGTH WAS MEASURED TO BE ~170.3CM. THE APOLLO USABLE LENGTH WAS MEASURED TO BE ~163.9CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION 165.0CM ± 2.5CM). THE APOLLO DISTAL FLOPPY SEGMENT WAS MEASURED TO BE ~25.8CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION 25.0CM +2CM -1CM). NO FLASH OR MOLDED VOIDS WERE OBSERVED WITH THE APOLLO MICRO CATHETER HUB; HOWEVER, THE HUB WAS FOUND TO BE OCCLUDED WITH ONYX. NO BENDS OR KINKS WERE FOUND WITH THE CATHETER BODY. THE DETACHABLE 5.0CM TIP WAS FOUND TO BE INTACT. THE DISTAL TIP WAS FOUND TO BE OCCLUDED WITH ONYX. NO OTHER ANOMALIES WERE OBSERVED. THE ONYX 18 VIALS (PART: 50067-060-1 LOT: A976615) WERE EXAMINED. REVIEW OF THE LOT HISTORY RECORDS OF THE ONYX 18 KIT (A992791) REVEALS THE ONYX 18 VIAL SUB-ASSEMBLY (PART: 50067-060-1 LOT: A976615) WAS USED. IT APPEARS THE CORRECT ONYX 18 VIALS WERE RETURNED. THE TAB OF THE ALUMINUM CAP ON THE ONYX 18 VIALS WERE OBSERVED TO BE REMOVED AND THE RUBBER STOPPERS WERE OBSERVED TO BE PUNCTURED. THE ONYX 18 VIALS WERE OBSERVED TO HAVE THEIR SOLUTIONS CONSUMED. NO DAMAGES WERE FOUND ON THE OUTSIDE OF THE VIALS. NO OTHER ANOMALIES WERE OBSERVED. THE APOLLO MICRO CATHETER WAS UNABLE TO BE FLUSHED OR TESTED WITH AN IN-HOUSE MANDREL, AS IT WAS FOUND TO BE OCCLUDED WITH ONYX. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER OCCLUSION¿ WAS CONFIRMED. A MANDREL WAS UNABLE TO BE INSERTED THROUGH THE MICROCATHETER HUB AS IT WAS FOUND TO BE OCCLUDED. HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. IT IS POSSIBLE THAT THE ONYX BECAME EXPOSED TO WATER, SALINE OR BLOOD CAUSING THE ONYX TO SOLIDIFY. THIS CAN OCCUR IN THE HUB, CATHETER LUMEN, OR THE NEEDLE USED TO DRAW THE ONYX FROM THE VIAL. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RESISTANCE¿ WAS CONFIRMED. IN ADDITION, AN IN-HOUSE MANDREL WAS UNABLE TO PASS THROUGH THE RETURNED APOLLO MICRO CATHETER HUB DUE TO OCCLUSION. IT¿S LIKELY THE CAUSE OF CATHETER RESISTANCE WAS CATHETER OCCLUSION. OTHER POSSIBLE CONTRIBUTING FACTORS TO ¿CATHETER RESISTANCE¿ INCLUDE THE USE OF AN INCOMPATIBLE DEVICE, FAILURE TO PREPARE THE ANCILLARY DEVICES PRIOR TO USE, AND INSUFFICIENT CATHETER FLUSH. 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.
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.
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.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS CURRENTLY RECOVERING. THERE HAD BEEN NO LONG PAUSES OF OVER 2 MINUTES DURING THE INJECTION. THERE WAS NO RESISTANCE NOTED DURING THE DMSO INJECTION.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT ONLY 4 OF THE 10 VIALS USED HAD THE PACKAGING ISSUE. THERE HAD BEEN NO DAMAGE OR EVIDENCE OF TAMPERING TO DEVICE PACKAGING. THE SECOND CATHETER USED WAS AN APOLLO. A CAUSE FOR THE BLEED IN THE VESSEL WAS NOT DETERMINED, THOUGH THE DOCTOR THEORIZED IT MAY HAVE BEEN A VASOSPASM. THE PATIENT WAS RECOVERING FROM THE PROCEDURE. NO ADDITIONAL ADVERSE EVENTS OR ANY MEDICAL/SURGICAL INTERVENTIONS HAVE BEEN PERFORMED TO TREAT THE HEMORRHAGING.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED A REPORT THAT DURING THE INITIAL EMBOLIZATION, THE DOCTOR COMPLAINED OF THE ONYX NOT FEELING SMOOTH, THE INJECTION WAS COMING IN COLUMNS, BREAKING OFF, AND POOR VISUALIZATION . THE SPEED SETTING ON THE SHAKER WAS 8, AND THE ONYX WAS SHAKEN FOR MORE THAN 20 MINUTES. IT WAS NOTED THE VIALS DID NOT SIT FOR MORE THAN FIVE MINUTES PRIOR TO INJECTION SINCE INJECTION WAS PERFORMED IMMEDIATELY AFTER SHAKING. THE ONYX WAS CHANGED OUT TO CONTINUE EMBOLIZATION. LATER IN THE PROCEDURE, THE DOCTOR DECIDED TO EMBOLIZE A DIFFERENT FEEDER TO THE ARTERIOVENOUS MALFORMATION (AVM), BUT UPON CONNECTING THE SYRINGE, THERE WAS HIGH RESISTANCE DUE TO CATHETER OCCLUSION, AND THE DOCTOR WAS UNABLE TO VISUALIZE THE ONYX AGAIN. INJECTION WAS STOPPED, AND THE CATHETER WAS CHANGED OUT. THE VESSEL WAS RE-CATHETERIZED, AND A DIFFERENT BATCH OF ONYX WAS PREPARED. EMBOLIZATION WENT AS NORMAL, BUT WHEN PULLING THE CATHETER OUT AFTER A FEW MINUTES OF INJECTION, THE PATIENT ENCOUNTERED A BLEED IN THE VESSEL. THE VESSEL WAS ACCESSED AGAIN, AND THE BLEED WAS SUCCESSFULLY ARRESTED. IT WAS UNCLEAR IF THERE WAS ANY ISSUE WITH THE CATHETER OR ONYX. HOWEVER, IT WAS REALIZED THE ONYX VIALS LOT NUMBER WAS A976615 WHILE THE PACKAGING STATED A992791. POST-PROCEDURE EXPERT COMPUTERIZED TOMOGRAPHY (CT) IMAGING SHOWED THE PATIENT HAD A SMALL SUBDURAL AND SUBARACHNOID BLEEDING. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF AN ARTERIOVENOUS MALFORMATION (AVM) IN THE ELOQUENT REGION. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1124798 | APOLLO | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | 105-5095-000 | B020223 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention |