AXIUM 3D
Report
- Report Number
- 2029214-2023-00551
- Event Type
- Malfunction
- Date Received
- March 29, 2023
- Date of Event
- March 27, 2023
- Report Date
- June 5, 2023
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRD
- UDI-DI
- 00847536030091
- PMA / PMN Number
- K081465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
H3: PRODUCT ANALYSIS OF QC-8-30-3D, LOT#:B051357 AS FOUND CONDITION (CONDITION OF RETURNED DEVICE): THE PHENOM PLUS CATHETER AND AN AXIUM IMPLANT COIL WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN THEIR OPENED OUTER CARTONS AND WITHIN THEIR OPENED INNER POUCHES AND WITHIN INDIVIDUAL DISPENSER TRACKS. VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE PHENOM PLUS CATHETER HAS AN ID (INNER DIAMETER) OF 0.0445¿. AXIUM IMPLANT COILS SHOULD BE DELIVERED THROUGH A MICROCATHETER WITH A MINIMUM INSIDE DIAMETER OF 0.0165¿. THEREFORE, THE PHENOM PLUS CATHETER WAS FOUND TO BE COMPATIBLE FOR USE WITH THE AXIUM IMPLANT COIL. THE PHENOM PLUS TOTAL LENGTH WAS MEASURED TO BE ~128.5CM AND THE USEABLE LENGTH WAS MEASURED TO BE ~121.9CM WHICH IS WITHIN SPECIFICATION. NO DAMAGES WERE FOUND WITH THE PHENOM HUB. THERE APPEARED TO BE DAMAGED AT STRAIN RELIEF. THE STRAIN RELIEF WAS REMOVED, AND THE CATHETER BODY WAS FOUND TO BE FLATTENED. THE PHENOM PLUS CATHETER BODY WAS FOUND TO BE FLATTENED AT ~19.0CM FOR ~5.0CM FROM DISTAL TIP. NO DAMAGES OR IRREGULARITIES WERE FOUND WITH THE DISTAL MARKER BAND OR DISTAL TIP. NO OTHER ANOMALIES WERE OBSERVED. THE ACTUATOR INTERFACE WAS FOUND TO BE BROKEN. THE PUSHWIRE WAS FOUND TO BE BENT AT ~8.4CM FROM PROXIMAL END. THIS IS INDICATIVE OF DETACHMENT ATTEMPTS BY MECHANICAL AND MANUAL METHODS. THE COIN WAS FOUND TO BE NOT AGAINST THE LUMEN STOP. THE IMPLANT COIL WAS FOUND TO BE ALREADY DETACHED AND NOT RETURNED. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS (INCLUDING SEM REPORTS): THE PHENOM PLUS CATHETER WAS FLUSHED; WATER EXITED FROM THE DISTAL TIP. THE PHENOM PLUS CATHETER WAS THEN TESTED WITH AN IN-HOUSE MANDREL. THE MANDREL ENTERED HUB AND EXITED DISTAL TIP WITHOUT ISSUE. UNDER THE MICROSCOPE, THE OUTER JACKET WAS THEN REMOVED TO GAIN ACCESS TO THE COIN. THE COIN APPEARED TO BE IN GOOD CONDITION. THE COIN WAS MEASURED TO BE 0.089¿ AT 0.063¿, 0.099¿ AT 0.127¿, AND 0.099¿ AT 0.275¿ WHICH WAS FOUND TO BE WITHIN SPECIFICATION. THE LUMEN STOP WAS FOUND TO BE VISUALLY ACCEPTABLE. THE RETAINER RING WAS FOUND TO BE VISUALLY ACCEPTABLE; HOWEVER, WAS UNABLE TO BE ACCURATELY MEASURED. CONCLUSION: BASED ON THE ANALYSIS PERFORMED, THE CUSTOMERS REPORT OF ¿PREMATURE DETACHMENT¿ WAS CONFIRMED AS THE AXIUM PRIME WAS RETURNED WITH THE IMPLANT ALREADY DETACHED. HOWEVER, THE CAUSE COULD NOT BE DETERMINED. SINCE THE INCLUDED DETACH ELEMENT WAS NOT RETURNED FOR ANALYSIS, ANY CONTRIBUTING FACTORS COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR PREMATURE DETACHMENT ARE TORTUOUS ANATOMY, PUSHER ROTATION AND THE COIL NOT BEING RETRACTED IN A ONE-TO-ONE MOTION WITH THE IMPLANT PUSHER DURING REPOSITIONING. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RESISTANCE¿ WAS UNABLE TO BE CONFIRMED AS NO ISSUE WAS FOUND DURING CATHETER RESISTANCE TESTING WITH AN IN-HOUSE MANDREL AND THE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR ¿CATHETER RESISTANCE¿ ARE CONTINUOUS FLUSH RATE TOO LOW, CATHETER OR DELIVERY SYSTEM DAMAGE OR INSUFFICIENT DELIVERY SYSTEM HYDRATION. IT IS POSSIBLE THE DAMAGE (KINKED) FOUND WITH THE CATHETER BODY CONTRIBUTED TO THE RESISTANCE. BASED ON THE REPORTED INFORMATION AND THE DEVICE ANALYSIS THE CUSTOMER¿S REPORT OF ¿CATHETER CRUSHED¿ WAS CONFIRMED; HOWEVER, THE ROOT CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF FAILURE ARE USER ADVANCES OR RETRIEVES DEVICE AGAINST RESISTANCE OR PATIENT VESSEL TORTUOSITY. THE CUSTOMER REPORTED PATIENT VESSEL TORTUOSITY AS SEVERE. IT IS POSSIBLE PATIENT¿S SEVERE VESSEL TORTUOSITY CONTRIBUTED TO THE REPORTED FAILURE. 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 ECHELON 10 CATHETER USED MODEL # 105-5091-150, LOT # B450025. THE NAVIEN CATHETER USED MODE #: RFX07 2-115-08MP LOT # B451044. SOLITAIRE AB STENT USED MODEL # SAB-4-30, LOT # B372461. THERE WAS NO DELAY IN TREATMENT WITH THE COMPLICATIONS ENCOUNTERED DURING THE PROCEDURE; TREATMENT WAS COMPLETED IMMEDIATELY.
MEDTRONIC RECEIVED A REPORT THAT THE PHENOM CATHETER HAD RESISTANCE AND WAS FOUND CRUSHED, AND THE AXIUM COIL WAS FOUND PREMATURELY DETACHED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, RUPTURED, WIDE NECK ANEURYSM IN THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION WITH A MAX DIAMETER OF 9.4 MM AND A 4.5 MM NECK DIAMETER. THE ACCESSED VESSEL WAS THE RIGHT INTERNAL CAROTID ARTERY (ICA) WITH A DIAMETER OF 5.2 MM. IT WAS NOTED THE PATIENT'S BLOOD FLOW WAS NORMAL AND VESSEL TORTUOSITY WAS SEVERE. IT WAS REPORTED THAT THE PHYSICIAN PLANNED TO TREAT A WIDE NECK RIGHT MCA BIFURCATION ANEURYSM THROUGH STENT ASSISTED COILING. HE PUT SHUTTLE 7F LONG SHEATH IN RIGHT PETROUS ICA INSIDE THAT HE TOOK THIS PHENOM PLUS CATHETER ECHELON-10 MICROCATHETER. THEN HE TOOK VASCO+21 MICROCATHETER INSIDE PHENOM PLUS FOR DEPLOYING SOLITAIRE-AB STENT PLACED ECHELON-10 MICROCATHETER INSIDE ANEURYSM TO DEPLOY COILS. WHILE PUSHING VASCO-21, HE FELT A LOT OF RESISTANCE INSIDE THE PHENOM PLUS CATHETER. SO HE HAD TO TAKE EVERYTHING OUT FROM LONG SHEATH, HE AGAIN FELT SOME RESISTANCE WHILE TAKING OUT PHENOM PLUS. THEN IT WAS OBSERVED THAT PHENOM PLUS WAS PINCHED AT APPROXIMATELY 15CM FROM DISTAL MARKER. SO HE TOOK A NAVIEN 6F INSIDE SHUTTLE 7F LONG SHEATH. THEN WHILE DEPLOYING THIS QC-8-30-3D COIL AS 1ST COIL, IT GOT PREMATURELY DETACHED INSIDE THE ECHELON-10 MICROCATHETER WAS NOT GETTING PUSHED INSIDE THE ANEURYSM. SO AGAIN HE HAD TO TAKE OUT THIS COIL ALONG WITH ECHELON-10 OUT OF NAVIEN 6F. HE TOOK OUT THIS PREMATURELY DETACHED COIL FROM ECHELON-10 AGAIN HE HAD TO CATHETERIZE THE ANEURYSM THROUGH SAME ECHELON-10 MICROCATHETER FOR COMPLETING THE PROCEDURE. THIS PROCEDURE WENT LONG, SO UNFORTUNATELY SCRUBBED NURSE COULDN'T KEEP THIS DETACHED COIL SAFELY IT WAS LOST SOMEWHERE. THOUGH PUSHER WIRE OF THIS COIL ALONG WITH PHENOM PLUS WILL BE RETURNED FOR ANALYSIS PURPOSE. IT WAS REPORTED THE PHENOMCATHETER WAS CRUSHED IN THE DISTAL SECTION. IT WAS REPORTED THERE WAS COIL SEPARATION/BREAK/PREMATURE DETACHMENT THAT OCCURRED. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PUSHWIRE WAS BENT OR BROKEN. THIS WAS NOT DONE ON PURPOSE. THERE WAS NO FRICTION OR DIFFICULTY DURING DELIVERY. THE PHYSICIAN DID NOT REPOSITION THE COIL. THE PHYSICIAN DID NOT ATTEMPT TO DETACH THE COIL. THE PHYSICIAN DID NOT ROTATE THE DELIVERY PUSHER DURING THE PROCEDURE. THE CONTINUOUS FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED ASINDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE: ECHELON 10 MICROCATHETER, NAVIEN 6F CATHETER, VASCO 21 MICROCATHETER, SHUTTLE 7F SHEATH, AND SOLITAIRE AB STENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 910249 | AXIUM 3D | DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION | KRD | MICRO THERAPEUTICS, INC. DBA EV3 | QC-8-30-3D | B051357 | 00847536030091 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Male |