AXIUM PRIME BRPL 3D
Report
- Report Number
- 2029214-2020-01161
- Event Type
- Malfunction
- Date Received
- November 20, 2020
- Date of Event
- November 16, 2020
- Report Date
- February 9, 2021
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- KRD
- UDI-DI
- 00847536008182
- PMA / PMN Number
- K081465
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- PHYSICIAN
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.
H3: ANALYSIS OF THE AXIUM PRIME PUSHWIRE (LOT NO. A810402) FOUND THERE WAS NO IMPLANT COIL OR ECHELON-10 CATHETER RETURNED WITH THE PUSHWIRE. THE ECHELON 10 APPEARED TO BE COMPATIBLE FOR USE WITH THE AXIUM PRIME COIL AS IT HAS A LABELED INNER DIAMETER (ID) OF 0.017". KINKS AND BENDS WERE OBSERVED AT 9.0 CM TO 45.0 CM FROM THE PROXIMAL END. THE AI TO RELEASE WIRE CRIMPS, COUPLER TO AI CRIMPS, AND COUPLER TO PUSHER TUBE WELD ARE PRESENT AND INTACT; INDICATIVE OF MECHANICAL DETACHMENT WAS NOT ATTEMPTED. HOWEVER, THE PUSHER WAS FOUND BROKEN AT THE BREAK INDICATOR (MANUAL DETACHMENT LOCATION) WITH THE RELEASE WIRE PULLING BACK; IT APPEARED THAT THE MANUAL DETACHMENT WAS ATTEMPTED AT THIS LOCATION. THE COIN WAS NOT PRESENT AGAINST THE LUMEN STOP AS IT WAS PULLING BACK. THE SHIELD COIL WAS PRESENT AND INTACT; BUT STRETCHED. UNDER THE MICROSCOPE, THE OUTER JACKET WAS THEN REMOVED TO GAIN ACCESS THE COIN. THE COIN WAS MEASURED IN 3 LOCATIONS PER AND WAS FOUND TO BE WITHIN SPECIFICATIONS. MEASURED 0.076 MM @ 0.063 MM; MEASURED 0.086 MM @ 0.127 MM; MEASURED 0.095 MM @ 0.275 MM. THE INNER DIAMETER OF THE LUMEN STOP AND THE INNER DIAMETER OF THE RETAINER RING WERE FOUND TO BE VISUALLY ACCEPTABLE. THE LUMEN STOP INNER DIAMETER (ID) WAS MEASURED TO BE 0.00270¿ AND FOUND TO BE WITHIN SPECIFICATION (0.00220" MINIMUM - 0.0029" MAXIMUM). THE RETAINER RING INNER DIAMETER (ID) WAS MEASURED TO BE 0.00461¿AND FOUND TO BE WITHIN SPECIFICATION (0.00455"+/- 0.00010"). ALL OTHER SUBASSEMBLIES APPEARED TO BE NORMAL. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS PERFORMED, THE AXIUM PRIME COIL WAS CONFIRMED TO HAVE "COIL RESISTANCE IN CATHETER" AND "PREMATURE DETACHMENT" ISSUES. BASED ON THE RETURNED DEVICE, THERE WAS EVIDENCE OF MANUAL DETACHMENT ATTEMPT TO DETACH THE COIL AS THE PUSHER WAS FOUND BROKEN AT THE MANUAL DETACHMENT LOCATION WITH THE RELEASE WIRE PULLING BACK; SUBSEQUENTLY CAUSING THE IMPLANT COIL TO DETACH FROM ITS PUSHWIRE. IN ADDITION, KINKS AND BENDS WERE FOUND ON THE PUSHWIRE. IT IS LIKELY THAT THESE DAMAGES OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE THE AXIUM PRIME COIL THROUGH THE ECHELON 10 CATHETER AGAINST THE REPORTED RESISTANCE. HOWEVER, THE CAUSE FOR RESISTANCE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF RESISTANCE INCLUDE PATIENT TORTUOUS ANATOMY AND LACK OF CONTINUOUS FLUSH WITH HEPARINIZED SALINE DURING DELIVERY. SINCE THE ECHELON 10 CATHETER AND THE IMPLANT COIL WERE NOT RETURNED; ANY CONTRIBUTION OF ECHELON 10 CATHETER AND IMPLANT COIL TO THE REPORTED ISSUES COULD NOT BE DETERMINED. H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO C0702, C070601, AND C070603. CONCLUSION CODE UPDATED TO D15. 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. 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 INDICATED THE COIL DID PUSH OUT OF THE INTRODUCER SHEATH SMOOTHLY, AND THERE WAS NO KINK OR DAMAGE OBSERVED TO THE COIL AFTER REMOVAL.
NO ADDITIONAL INFORMATION RECEIVED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MEDTRONIC RECEIVED INFORMATION REGARDING AN AXIUM COIL THAT DETACHED PREMATURELY WITHIN THE MICROCATHETER. THE PATIENT WAS BEING TREATED FOR A RUPTURED SACCULAR ANEURYSM OF THE ANTERIOR COMMUNICATING ARTERY. THE ANEURYSM MAX DIAMETER WAS 6.6MM AND THE NECK DIAMETER WAS 2.1MM. BLOOD FLOW WAS NORMAL. VESSEL TORTUOSITY WAS MODERATE. IT WAS REPORTED THAT ALL DEVICES WERE PREPARED PER THE INSTRUCTIONS FOR USE (IFU). WHILE ATTEMPTED TO PLACE THE AXIUM COIL, IT DETACHED PREMATURELY IN THE MICROCATHETER. THERE HAD BEEN SOME FRICTION FELT DURING DELIVERY OF THE COIL THROUGH THE CATHETER. THERE WAS NO DAMAGE NOTED TO THE COIL PUSHWIRE. THE PHYSICIAN DID NOT REPOSITION THE COIL, ROTATE THE PUSHER, OR ATTEMPT TO DETACH THE COIL AT ANY POINT. CONTINUOUS CATHETER FLUSH WAS ADMINISTERED DURING THE PROCEDURE. THE CATHETER AND COIL WERE REMOVED TOGETHER FROM THE PATIENT'S BODY AND THE COIL WAS PULLED OUT FROM THE CATHETER. THERE WAS NO HARM OR INJURY TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1339030 | AXIUM PRIME BRPL 3D | DEVICE, EMBOLIZATION, VASCULAR | KRD | MICRO THERAPEUTICS, INC. DBA EV3 | APB-5-10-3D-SS | A810402 | 00847536008182 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |