BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PIPELINE FLEX

    MDR report key: 10564460 · Received September 21, 2020

    Report

    Report Number
    2029214-2020-00955
    Event Type
    Malfunction
    Date Received
    September 21, 2020
    Date of Event
    September 17, 2020
    Report Date
    December 16, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    OUT
    UDI-DI
    00847536016507
    PMA / PMN Number
    P100018.S011
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3: TWO PIPELINE FLEX EMBOLIZATION DEVICES (MODEL: PED-450-25 LOT: B013806) (PLI-10), (MODEL: PED-450-25 LOT: B013806) (PLI-20) AND TWO MARKSMAN CATHETERS (MODEL: FA-55150-1030 LOT: 218503390) (PLI-30) (MODEL: FA-55150-1030 LOT: 218503390) (PLI-40) WERE RETURNED FOR ANALYSIS. (PLI-10) THE PIPELINE PUSHWIRE WAS FOUND TO BE EXTENDING ~52.0CM FROM HUB. THE PIPELINE FLEX DEVICE WAS THEN REMOVED FROM THE MARKSMAN CATHETER (PLI-30). THE PIPELINE DISTAL END WAS INADVERTENTLY DETACHED FROM HYPOTUBE WHEN THE PIPELINE FLEX WAS REMOVED FROM MARKSMAN. THE PIPELINE PUSHWIRE WAS FOUND TO BE BENT AT ~35.6CM AND AT ~119.6CM FROM PROXIMAL END. THE DISTAL HYPOTUBE AND PTFE WERE FOUND TO BE INTACT. THE PROXIMAL BUMPER, RE-SHEATHING MARKER AND RE-SHEATHING PAD WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND TO BE INTACT. THE TIP COIL WAS FOUND TO BE DAMAGED. THE BRAID WAS NOT RETURNED. NO OTHER DAMAGES OR ANOMALIES WERE FOUND WITH THE DEVICE. (PLI-30) NO DAMAGES WERE FOUND WITH THE MARKSMAN HUB; HOWEVER, THE PIPELINE FLEX PUSHWIRE WAS FOUND EXTENDING ~52.0CM FROM THE MARKSMAN CATHETER HUB. THE MARKSMAN TOTAL LENGTH WAS MEASURED TO BE ~157.8CM (REFERENCE: 157.0CM ± 3CM). THE MARKSMAN USEABLE LENGTH WAS MEASURED TO BE ~150.4CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 150.0CM ± 3CM). THE MARKSMAN CATHETER BODY WAS FOUND TO BE ACCORDIONED AT ~30.0CM FOR ~6.3CM AND KINKED AT ~4.1CM AND AT ~3.5CM FROM DISTAL TIP. NO DAMAGES WERE FOUND WITH THE DISTAL TIP. THE CATHETER WAS FLUSHED, AND WATER EXITED THE DISTAL TIP WITHOUT ISSUE. THE MARKSMAN CATHETER WAS TESTED WITH AN IN-HOUSE 0.026IN MANDREL. THE IN-HOUSE MANDREL WAS INSERTED INTO THE MARKSMAN AND WAS ABLE TO PASS THROUGH THE DISTAL TIP WITHOUT ISSUE. NO OTHER ANOMALIES WERE OBSERVED. (PLI-20) THE PIPELINE PUSHWIRE WAS FOUND TO BE EXTENDING ~47.5CM FROM HUB AND ~1.4CM FROM DISTAL TIP. THE PIPELINE FLEX DEVICE WAS THEN REMOVED FROM THE MARKSMAN CATHETER (PLI-40). NO BENDS OR KINKS WERE FOUND WITH THE PIPELINE FLEX PUSHWIRE. THE HYPOTUBE WAS FOUND TO BE INTACT WITH NO ELONGATION OF THE PTFE. THE PROXIMAL BUMPER, RE-SHEATHING MARKER AND RE-SHEATHING PAD WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND TO BE INTACT BUT DAMAGED. NO DAMAGES WERE FOUND WITH THE TIP COIL. THE BRAID WAS NOT RETURNED. NO OTHER DAMAGES OR ANOMALIES WERE FOUND WITH THE DEVICE. (PLI-40) NO DAMAGES WERE FOUND WITH THE MARKSMAN HUB; HOWEVER, THE PIPELINE FLEX PUSHWIRE WAS FOUND EXTENDING ~47.5CM FROM THE MARKSMAN CATHETER HUB AND ~1.4CM FROM DISTAL TIP. THE MARKSMAN TOTAL LENGTH WAS MEASURED TO BE ~157.0CM (REFERENCE: 157.0CM ± 3CM). THE MARKSMAN USEABLE LENGTH WAS MEASURED TO BE ~149.3CM WHICH IS WITHIN SPECIFICATION (SPECIFICATION: 150.0CM ± 3CM). THE MARKSMAN CATHETER BODY WAS FOUND TO BE ACCORDIONED AT ~30.0CM FOR ~5.3CM FROM DISTAL TIP. NO DAMAGES WERE FOUND WITH THE DISTAL TIP. THE CATHETER WAS FLUSHED, AND WATER EXITED THE DISTAL TIP WITHOUT ISSUE. THE MARKSMAN CATHETER WAS TESTED WITH AN IN-HOUSE 0.026IN MANDREL. THE IN-HOUSE MANDREL WAS INSERTED INTO THE MARKSMAN AND WAS ABLE TO PASS THROUGH THE DISTAL TIP WITHOUT ISSUE. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿FAILURE/INCOMPLETE OPEN DISTAL¿ WAS UNABLE TO BE CONFIRMED AS THE PIPELINE FLEX BRAIDS WERE NOT RETURNED. POSSIBLE CAUSES COULD BE VESSEL TORTUOSITY OR RE-SHEATHING THE DEVICE MORE THAN THE RECOMMENDED TWO TIMES. FURTHERMORE, THE REVIEW OF LOT HISTORY RECORDS SHOWS THAT THE FINISHED DEVICE HAS MET ALL MANUFACTURING REQUIREMENTS AND SPECIFICATIONS DURING FINAL ASSEMBLY AND QUALITY INSPECTION. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿LOCKUP/RESISTANCE AT DISTAL SEGMENT OF CATHETER¿ WAS CONFIRMED. THE INVESTIGATION DETERMINED THAT THIS EVENT WAS SIMILAR TO AN EVENT THAT HAD ALREADY BEEN INVESTIGATED, AND ANOTHER INVESTIGATION IS NOT NECESSARY. BASED ON THE INVESTIGATION CONDUCTED RESISTANCE CAN OCCUR DURING TRACKING, DEPLOYMENT AND RE-SHEATHING OF THE DEVICE IN DISTAL AND TORTUOUS ANATOMIES. HOWEVER, THE CAUSE FOR THE RESISTANCE COULD NOT BE DETERMINED. BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿CATHETER RESISTANCE¿ WAS CONFIRMED DUE TO ITS DAMAGED (ACCORDIONED) CONDITION. THE CAUSE FOR THE DAMAGE COULD NOT BE DETERMINED. IT IS POSSIBLE THE DAMAGES OCCURRED WHEN THE CUSTOMER ATTEMPTED TO ADVANCE/RETRIEVE THE PIPELINE DEVICE THROUGH THE MARKSMAN CATHETER AGAINST RESISTANCE. 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 Manufacturer Narrative · 0

    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 Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE FIRST PIPELINE REACHED THE TARGET LOCATION WITH THE MARKSMAN MICROCATHETER. HOWEVER, DURING THE DEPLOYMENT PROCESS, THE PIPELINE FAILED TO OPEN IN THE DISTAL SEGMENT. THE SURGEON FOLLOWED THE INSTRUCTIONS, RE-SHEATHED, AND REDEPLOYED THE STENT MORE THAN TWICE, THEN WAITED FOR MORE THAN 10 MINUTES EACH TIME. THE SLACK IN THE SYSTEM WAS RELEASED AS WELL, BUT THE STENT STILL WOULD NOT OPEN. MORE THAN 50% HAD BEEN DEPLOYED, THE STENT WAS NOT IN A BEND, AND NO ADDITIONAL STEPS WERE TAKEN TO OPEN THE DEVICE. IT WAS ALSO STATED THE STENT BECAME LOCKED UP IN THE DISTAL SEGMENT OF THE MARKSMAN EVEN THOUGH A CONTINUOUS FLUSH WAS USED. THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE. THE DEVICES WERE REMOVED FROM THE PATIENT. A NEW PIPELINE, AND MARKSMAN OF THE SAME MODEL/LOT# WERE USED, BUT THE SECOND PIPELINE BECAME STUCK AT THE DISTAL END OF THE MARKSMAN DURING DELIVERY. THE SLACK WAS RELEASED IN THE SYSTEM, BUT THE ISSUE DID NOT RESOLVE. THE DISTAL SEGMENT OF THE SECOND MARKSMAN BECAME ACCORDIONED, AND THERE WAS NO DAMAGE TO THE PIPELINE PUSHWIRE. REPLACEMENT PRODUCTS WERE USED AGAIN, AND THE PROCEDURE WAS COMPLETED WITHOUT ISSUE. IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. POST-PROCEDURE ANGIOGRAPHIC RESULTS SHOWED THE BLOOD FLOW DIVERSION WAS SATISFIED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM OF THE CAVERNOUS SINUS SEGMENT WITH A MAX DIAMETER OF 7.88 MM AND A 5.18 MM NECK DIAMETER. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1025368 PIPELINE FLEX LASER THERAPY PRODUCT OUT MICRO THERAPEUTICS, INC. DBA EV3 PED-450-25 B013806 00847536016507

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR