PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2020-01302
- Event Type
- Malfunction
- Date Received
- December 14, 2020
- Date of Event
- December 9, 2020
- Report Date
- April 12, 2021
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
Narratives
B5 UPDATED WITH ADDITIONAL INFORMATION RECEIVED. 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 PIPELINE FLEX W/ SHIELD (MODEL: PED2-475-20 LOT: A915540) AND MARKSMAN MICRO CATHETER (MODEL: FA-55150-1030 LOT: 219359299) FOUND THAT THE PIPELINE FLEX W/ SHIELD WAS STILL WITHIN THE CATHETER WITH THE DISTAL BRAID AND DISTAL DELIVERY WIRE PARTIALLY DEPLOYED OUT OF THE DISTAL TIP. THE MICRO CATHETER WAS FLUSHED WITH WATER AND WATER DID NOT EXIT THE DISTAL END. RESISTANCE WAS ENCOUNTERED WHEN EXTRACTING THE PIPELINE FLEX W/ SHIELD. THE INNER DIAMETER OF THE MARKSMAN WAS MEASURED TO BE 0.027¿ WHICH IS WITHIN SPECIFICATION AND COMPATIBLE FOR USE WITH THE PIPELINE FLEX W/ SHIELD. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.0260¿ MANDREL THROUGH MICROCATHETER. THE MANDREL PASSED THROUGH THE CATHETER HUB, CATHETER BODY AND DISTAL TIP WITH RESISTANCE ENCOUNTERED NEAR THE DISTAL END. THE PIPELINE FLEX W/ SHIELD PUSHER CORE WIRE WAS FOUND UNBENT AND UNDAMAGED. WHEN COMPARED TO THE DRAWING, THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. THE DISTAL 18.2 CM OF THE HYPOTUBE WAS FOUND BENT, HOWEVER, THE PTFE SHRINK TUBING WAS STILL INTACT. THE DISTAL HYPOTUBE WAS FOUND BROKEN. NO DAMAGES WERE FOUND WITH THE PROXIMAL BUMPER. THE RESHEATHING PAD AND PAD RESTRAINTS WERE FOUND LOOSE ON THE DISTAL WIRE. THE TIP COIL WAS FOUND INTACT AND UNSTRETCHED. ONCE FULLY DEPLOYED OUT OF THE MICRO CATHETER, THE DISTAL END OF THE PIPELINE FLEX SHIELD BRAID WAS FOUND FULLY OPENED. THE PROXIMAL END DID NOT FULLY OPEN. BLOOD WAS FOUND ON THE PROXIMAL BRAID AND HYPOTUBE. THE BLOOD WAS DISSOLVED IN AN ULTRASONIC CLEANER AND THE PROXIMAL END FULLY OPENED. BOTH ENDS OF THE BRAID WERE FOUND DAMAGED AND FRAYED. THE BROKEN HYPOTUBE WAS SENT OUT FOR SEM TESTING. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS, THE CUSTOMER REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL¿ COULD NOT BE CONFIRMED AS THE DEVICE FULLY OPENED WHEN DEPLOYED OUT OF THE MICRO CATHETER AND THE BLOOD WAS DISSOLVED. THE CAUSE COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR FAILURE ARE PATIENT VESSEL TORTUOSITY, DAMAGED BRAID, BRAID IMPROPERLY SIZED TO ANATOMY, BRAID OVERSTRETCHED DURING DELIVER, USER DEPLOYS BRAID IN VESSEL BEND, PRESENCE OF OTHER INDWELLING ENDOVASCULAR STENT AND INAPPROPRIATE ANATOMY. CUSTOMER REPORTED ANATOMY AS NOT DIFFICULT, AND DEVICE WAS NOT PLACED IN A VESSEL BEND. THE DAMAGE TO THE DISTAL SECTION OF THE MARKSMAN COULD HAVE CONTRIBUTED TOWARDS THE FAILURE TO OPEN. POSSIBLE CAUSES OF CATHETER ST RETCH, ACCORDION AND BENT ARE PATIENT VESSEL TORTUOSITY, CATHETER ENTRAPMENT, OR USER ADVANCES/RETRIEVES INTRALUMINAL DEVICE AGAINST RESISTANCE. THE MARKSMAN CATHETER LENGTH WAS OUT OF SPECIFICATION, LIKELY DUE TO THE STRETCHING FOUND ON THE CATHETER. FROM THE DAMAGES FOUND ON THE CATHETER (STRETCH/ACCORDION/BENT) PUSHER HYPOTUBE (BEND/BREAK), RESHEATHING PAD/RESTRAINT (BREAK) AND BRAID (DAMAGED/FRAYED), IT APPEARS HIGH FORCE IS USED. IT IS POSSIBLE THESE DAMAGES OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE/RETRIEVE THE PIPELINE FLEX SHIELD THROUGH THE PHENOM CATHETER AGAINST RESISTANCE. POSSIBLE CONTRIBUTORS TOWARDS THE FAILURE ARE PATIENT VESSEL TORTUOSITY OR LACK OF CONTINUOUS FLUSH. THE SEM/EDS REPORT CONCLUDED THAT ¿MOST OF THE FRACTURE SURFACE EXHIBITS CORROSION DAMAGE. DIMPLE FEATURES CONSISTENT WITH AN OVERLOAD TYPE OF FAILURE MECHANISM ARE VISIBLE IN THE SMALL FRACTURE AREA.¿ POSSIBLE CONTRIBUTORS TOWARDS FAILURE ARE PATIENT VESSEL TORTUOSITY, RESISTANCE DURING DELIVERY/RETRIEVAL, OVER-MANIPULATION, CATHETER DAMAGE OR USER RE-SHEATHS MORE THAN TWO TIMES. H6: METHOD CODE UPDATED TO B01. RESULT CODE UPDATED TO 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. 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 PIPELINE DEVICE WAS NOT PLACED IN A VESSEL BEND WHEN FAILURE TO OPEN OCCURRED. NO OTHER STEPS THAN THOSE PREVIOUSLY REPORTED WERE ATTEMPTED TO OPEN THE PIPELINE.
NO ADDITIONAL INFORMATION RECEIVED.
ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE STENT WAS REMOVED AS A RESULT OF THE ISSUE. THE PROCEDURE WAS COMPLETED USING A COMPETITOR STENT. IT WAS ALSO CONFIRMED THAT THERE WAS NO BREAK, ONLY THAT THE DEVICE FAILED TO OPEN IN THE DISTAL END.
PLEASE SEE MFG REPORT (B)(4) AND (B)(4) FOR ADDITIONAL DEVICES ASSOCIATED WITH THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT WAS DIAGNOSED WITH UNRUPTURED, SACCULAR ANEURYSMS OF THE RIGHT INTERNAL CAROTID ARTERY, CAVERNOUS, AND OPHTHALMIC SEGMENTS, AND THEY UNDERWENT ENDOVASCULAR PROCEDURE ON (B)(6) 2020, TO TREAT THE LESIONS. IT HAPPENED THAT 3 PIPELINE FLOW REDIRECTING STENTS WERE DISCARDED AFTER THE DEVICES FAILED TO BE RELEASED. THE FIRST, A 5 X 18MM PIPELINE (REFERENCE: PED2 - 500-18, LOT: A850790), DID NOT OPEN DISTALLY AS EXPECTED, EVEN AFTER ATTEMPTS TO RECAP THE STENT WITH REPOSITIONING. IN AN ATTEMPT TO REMOVE THE DEVICE FROM THE MARKSMAN MICROCATHETER, IT BROKE INSIDE THE MICROCATHETER WITHOUT US NOTICING AND A SECOND 5 X 20MM PIPELINE STENT (REFERENCE: PED2-500-20, LOT: A737153) WAS LOST, AS IT WAS NOTICED IN TIME THAT THE SAME PUSHED THE ANTERIOR STENT INTO THE PATIENT'S MIDDLE CEREBRAL ARTERY. THE PROCEDURE WAS THEN INTERRUPTED WITH THE REMOVAL OF THE PATIENT'S MICROCATHETER AND WITH NO SAFE POSSIBILITY OF "SAVING" THE 5 X 20MM PIPELINE, THEY OPTED FOR DISPOSAL. BUT STILL A THIRD PIPELINE, THIS TIME A 4.75 X 20MM (REFERENCE: PED2-475-20, LOT: A915540), WAS PASSED THROUGH A NEW MARKSMAN CATHETER WITHOUT AGAIN BEING SUCCESSFUL, SINCE THE BEHAVIOR OF THE STENT WAS EXACTLY THE SAME AS OF THE FIRST. THE PATIENT'S TREATMENT WAS ONLY CARRIED OUT SAFELY AND SUCCESSFULLY AFTER CHANGING THE MICROCATHETER FOR A 155 CM NEUROSLIDER® 0.027 "THROUGH WHICH A DERIVO® 5 X 20MM STENT (ACANDIS GMBH) WAS PASSED, IN A FEW MINUTES, WITHOUT ANY TYPE OF RESISTANCE OR DIFFICULTY. THE DOCTOR INDICATED THAT THE ARTERIAL ROUTE WAS NOT DIFFICULT, AND THEY OBEYED ALL THE MANUFACTURER'S RECOMMENDATIONS FOR ITS IMPLANTATION. IT WAS NOTED THE DAPT (DUAL ANTI-PLATELET TREATMENT) WAS ADMINISTERED. THERE WERE NO PATIENT SYMPTOMS ASSOCIATED WITH THE EVENT. THE DEVICES WERE PREPARED/FLUSHED AS INDICATED IN THE IFU.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1466027 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-475-20 | A915540 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |