APOLLO
Report
- Report Number
- 2029214-2021-01533
- Event Type
- Malfunction
- Date Received
- November 30, 2021
- Date of Event
- November 18, 2021
- Report Date
- February 2, 2022
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- MFE
- PMA / PMN Number
- P030004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
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.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ANALYSIS: AS FOUND CONDITION: THE APOLLO MICRO CATHETER WAS RETURNED INSIDE OF THE BIOHAZARD BAG AND A SHIPPING BOX.. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE APOLLO TOTAL LENGTH WAS MEASURED TO BE ~171.5CM. THE USABLE LENGTH WAS MEASURED TO BE ~166.0M WHICH IS WITHIN SPECIFICATION AND THE DISTAL FLOPPY LENGTH WAS MEASURED TO BE ~25.5CM WHICH IS WITHIN SPECIFICATION. THE SQID LIQUID EMBOLIC WAS FOUND SOLIDIFIED WITHIN THE APOLLO HUB. NO DAMAGES WERE FOUND WITH THE APOLLO DISTAL MARKER/TIP. THE APOLLO DISTAL TIP AND LUMEN WAS FOUND TO BE OCCLUDED WITH SOLIDIFIED SQID LIQUID EMBOLIC. THE ENTIRE SURFACE OF THE APOLLO MICRO CATHETER BODY WAS EXAMINED UNDER MAGNIFICATION. THE APOLLO MICRO CATHETER BODY WAS FOUND TO BE RUPTURED AT ~22.0CM FROM THE DISTAL TIP. TESTING/ANALYSIS: THE APOLLO MICRO CATHETER WAS PRESSURIZED WITH WATER AND FOUND NON-PATENT AS IT WAS FOUND TO BE OCCLUDED WITH THE SQID LIQUID EMBOLIC. CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER LEAK¿ WAS CONFIRMED AS THE RETURNED APOLLO MICRO CATHETER WAS FOUND RUPTURED. THE RUPTURE APPEARS TO HAVE OCCURRED AS A RESULT OF OVER-PRESSURIZATION. RUPTURE CAN OCCUR DURING INJECTION OF EMBOLIC MATERIAL OR WHEN THE DISTAL PORTION OF THE CATHETER IS KINKED, PROLAPSED, OR OCCLUDED. RUPTURE CAN ALSO OCCUR DUE TO HIGH INJECTION RATE, USE OF PALM OF HAND PRESSURE, INCREASED INJECTION FORCE AGAINST RESISTANCE. THERE WAS NO NON-CONFORMANCE TO SPECIFICATIONS IDENTIFIED THAT LED TO THE REPORTED ISSUE. THE REVIEW OF LOT HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY INSPECTION. 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 WAS RECEIVED INDICATING THERE WERE NO ISSUES THAT RESULTED IN THE LEAK THAT WAS FOUND. THE EMBOLIZATION WENT SMOOTH AND WITHOUT ANY MASSIVE PRESSURE. THERE WAS NO LONGER PAUSE WHILE INJECTING AND THE SPEED OF THE INJECTION WAS SLOW AND CONSTANT.
MEDTRONIC RECEIVED A REPORT THAT THERE WAS A LEAK WITH THE APOLLO CATHETER. THE PATIENT WAS UNDERGOING TREATMENT FOR AN ARTERIOVENOUS MALFORMATION (AVM). THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. IT WAS REPORTED THAT A LEAK IN THE MIDDLE TO PROXIMAL SEGMENT WAS NOTICED WHEN INJECTING THE LIQUID EMBOLIC. THE SQID LIQUID EMBOLIC FLUID COULD BE INJECTED WITHOUT EXCESSIVE PRESSURE AND IT STILL RAN OUT OF THE DISTAL TIP WHEN IT WAS NOTICED LEAKING MORE PROXIMAL. THE CATHETER WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). ANCILLARY DEVICES INCLUDE AN ENVOY GUIDE CATHETER, BALT SONIC MICROCATHETER, BALT HYBRID GUIDEWIRE, SQID 18 LIQUID EMBOLIC, AND SQID 12 LIQUID EMBOLIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1795946 | APOLLO | AGENT, INJECTABLE, EMBOLIC | MFE | MICRO THERAPEUTICS, INC. DBA EV3 | 105-5097-000 | B077253 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 11 YR | Male |