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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-30
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
See manufacturer report # 2029214-2020-00852 for the pipeline that failed to open. : two pipeline flex (model: ped-500-25 lot: b027931) (model: ped-500-30 lot: b013893) and two phenom-27 micro catheters (model: fg 15150-0615-1s lot: nv19-035) were returned for analysis. It was not possible to determine which device belong to which pli. (first pipeline flex and phenom-27) the phenom-27 micro catheter total length was measured to be ~158. 7cm, the usable length was measured to be ~152. 1cm and the distal single coil length was found to be 14. 8cm, which is within specification (specification: total (ref)
=
156. 5cm, usable
=
150cm ± 5cm, distal single coil
=
15cm ± 2cm). No flash or voids molded were found within the catheter hub, however an occlusion was found within the hub. No damages or anomalies were found with the hub. The phenom-027 micro catheter body was found kinked at ~44. 4cm and ~134. 2cm from the proximal end and found kinked at ~2. 0cm from the distal end. No damages or irregularities were found with the distal tip or marker band. The micro catheter was flushed, and water did not exit the distal end. An in-house 0. 0260¿ mandrel was inserted into the hub and became stuck. The mandrel was inserted into the distal end and became stuck at ~2. 0cm. The occlusion could not be pushed out. The phenom-27 catheter was destroyed to remove the braid/distal wire. No damages were found with the proximal pipeline flex pusher. The hypotube was found stretched. The distal wire was separated from the hypotube proximal to the wire weld. The coil tip and dps sleeves were found damaged, caused at least in part during extraction from the phenom-27 micro catheter. The distal wire could not be found. One end of the braid was found slightly tapered, frayed and damaged. The other end fully opened and found frayed. The hypotube was sent out for eds testing. No other anomalies were observed. Based on the analysis findings, the customer report of ¿movement during deployment¿ could not be confirmed as this complaint cannot be confirmed based on device evaluation and the customer did not send any video/pictures of the event. Possible causes of failure include vasospasm, patient vessel tortuosity, high delivery force, catheter kickback, insufficient distal anchoring of braid, or incorrect braid size. The customer report of ¿failure/incomplete to open¿ was confirmed. 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 the device was not placed in vessel bend, there was not any friction/difficulty during delivery or positioning, the device did not jump during deployment, nor was the tip of the catheter moved during deployment. The elemental analysis of the hypotube hole showed presence of tin (sn). Separation can occur if excessive force is used exceeding the tensile strength of the material. Regarding the solder joint separation issue, in addition to excessive force, separation can occur due to inadequate solder/tinning. As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted. A review of the manufacturing process did not uncover any deficiencies with regard to the soldering process. Proper soldering technique and surface preparation (tinning) were well defined and documented appropriately in the associated manufacturing procedures. The proof load of 2. 5n performed on 100% of the devices (section starting with hypotube solder to distal pad solder joint). From the damages seen on the catheter body (kinking), distal wire (separation from hypotube) and braid (frayed/damaged); it appears there was high force used. It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex shield through the marksman catheter against resistance. Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush. (second pipeline flex and phenom-27) the phenom-27 micro catheter total length was measured to be ~158. 4cm, the usable length was measured to be ~151. 9cm and the distal single coil length was found to be 15. 0cm, which is within specification (specification: total (ref)
=
156. 5cm, usable
=
150cm ± 5cm, distal single coil
=
15cm ± 2cm). No flash or voids molded were found within the catheter hub, however an occlusion was found within the hub. No damages or anomalies were found with the hub. The phenom-027 micro catheter body was found kinked at ~15. 9cm from the proximal end and found kinked at ~0. 9cm from the distal end. No damages or irregularities were found with the distal tip or marker band. The micro catheter was flushed, and water did not exit the distal end. An in-house 0. 0260¿ mandrel was inserted into the hub and became stuck. Blood and particulates were found on the tip of the mandrel when retracted back out. The mandrel was inserted into the distal end and became stuck at ~0. 9cm. The occlusion could not be pushed out. The phenom-27 catheter was destroyed to remove the braid/distal wire. The pipeline flex pusher was found bent at ~151. 8cm from the proximal end. The hypotube was found stretched and ptfe shrink tubing was still intact. No damages were found with the distal marker, re-sheathing marker or with the proximal bumper. The distal wire was found broken between the re-sheathing pad and the dps sleeves. The distal segment was found within second phenom-27 micro catheter. The coil tip and dps sleeves were found damaged, caused at least in part during extraction from the phenom-27 micro catheter. Both ends of the braid were found tapered, frayed and damaged. The broken end was sent out for sem analysis. Sem summary: the wire failed via torsional overload. Based on the analysis findings, the customer report of ¿movement during deployment¿ could not be confirmed as this complaint cannot be confirmed based on device evaluation and the customer did not send any video/pictures of the event. Possible causes of failure include vasospasm, patient vessel tortuosity, high delivery force, catheter kickback, insufficient distal anchoring of braid, or incorrect braid size. The customer report of ¿failure/incomplete to open¿ was confirmed. 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 the device was not placed in vessel bend, there was not any friction/difficulty during delivery or positioning, the device did not jump during deployment, nor was the tip of the catheter moved during deployment. From the damages seen on the catheter body (kinking), distal wire (break) and braid (frayed/damaged); it appears there was high force used. It is possible these damages occurred when the customer attempted to advance/retrieve the pipeline flex shield through the marksman catheter against resistance. Possible contributors towards the failure are patient vessel tortuosity or lack of continuous flush. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that one pipeline failed to open, and both pipelines had difficult placement due to system tension resulting in device replacement. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the left posterior communicating (pcom) artery with a max diameter of 14mm and a 9. 4mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered and the pru level was normal. It was reported that the surgeon successfully delivered the phenom 27 microcatheter (pli-30) to the middle cerebral artery m2. The pipeline (pli-10) was delivered in place, and deployed 8mm, but the stent tip did not open. The surgeon tried multiple times, but the tip still did not open. The phenom 27 and pipeline were pulled to the thicker side of the internal carotid artery, and another attempt was made to open the device. System tension caused the distal part of the entire system to fall into the aneurysm, and it could not be put in place for deployment again. The surgeon retrieved the stent and withdrew the stent and microcatheter. A new phenom27 (pli-40) and pipeline (pli-20) were then placed in the middle cerebral artery (mca). The tip of the pipeline opened smoothly, and the surgeon decided to drag the stent to the predetermined distal landing position. The system tension caused the distal part of the entire system to fall into the aneurysm again. Again, the microcatheter and pipeline were removed from the patient. A marksman microcatheter and a third pipeline were then used, and the deployment was smooth. Adherence was good, and post-procedure angiographic results showed good results and blood retention. 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. It was also reported that in the two systems, the surgeon tried to push out the stent in vitro, and it was found the guidewire was pushed out but the implantation was not pushed out at the distal end. It was stated it was possible the guidewire was broken and the implantation was stuck in the phenom27. However, this was not confirmed, and conflicts the previously reported information. Ancillary devices include a navien catheter. Additional information received reported that the distal section of the pipeline did not open. The device had not been placed in a vessel bend at the time, and there was not any friction/difficulty during delivery or positioning. The device did not jump during deployment, nor was the tip of the catheter moved during deployment. No additional steps were attempted to open the pipeline.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key10956487
MDR Text Key226887781
Report Number2029214-2020-01240
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/06/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-30
Device Catalogue NumberPED-500-30
Device Lot NumberB013893
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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