• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-500-25
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/29/2020
Event Type  malfunction  
Manufacturer Narrative
No damages or irregularities were found with the returned introducer sheath. The hypotube was found stretched. The distal delivery wire was found separated from the hypotube proximal to the wire weld. Under a microscope, the hypotube hole was examined and solder was found around the opening. The distal delivery wire was not returned for analysis. The pipeline flex device could not be used for resistance in catheter hub testing due to the damages. The hypotube was sent out for sem and eds testing. The marksman catheter total length was measured and found to be ~157. 6cm and the usable length was found to be ~150. 8cm which is within specification per drawing: total length (reference)
=
157cm ± 3cm and usable length
=
150cm ± 3cm. No damages or irregularities were found with the marksman catheter hub. No flash or voids molded were observed in the hub; however, dried blood and contrast were found within the hub. The marksman micro catheter body was found kinked at ~27. 1cm, ~4. 2cm and ~2. 0cm from the distal end as well as directly proximal to the marker band. The marker band and distal tip was found intact. The marksman catheter was flushed; however, the micro catheter was found occluded as no water exited the distal end. A 0. 0260¿ mandrel was then used for resistance testing. The mandrel became stuck at the hub and distal tip and could not be inserted into the micro catheter. The inner diameter could not be measured. Dried blood was found stuck within the micro catheter and further resistance testing could not be performed. No other anomalies were observed. Based on the analysis findings, the customer report of ¿lockup/resistance at distal segment of catheter¿ could not be confirmed. The customer report of ¿catheter resistance¿ was confirmed. T he cause of the resistance at time of analysis was the large amount of dried blood found within the catheter. Any other contributing factors for resistance could not be assessed as the catheter was found fully occluded by blood. The customer report of ¿catheter accordion¿ was not confirmed, however, the catheter was found to be kinked distally. From the damages seen on the pipeline flex pusher hypotube (stretch), separation of the distal wire from the hypotube and the catheter (kinking); it appears there was high force used. It is likely these damages occurred when the customer attempted to retract the pipeline flex through the marksman catheter against resistance. The end of the detached distal wire was sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis. The elemental analysis of the detached pushwire end showed presence of tin (sn). 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). There was no non-conformance to specification that lead to the resistance and detachment issues. The marksman catheter has a labeled inner diameter of 0. 027¿ which is compatible for use with the pipeline flex. As the braid and distal delivery wire were not returned, any contribution of the braid or distal delivery wire could not be assessed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that after the marksman microcatheter was positioned, the pipeline became stuck and experienced resistance at the distal end during delivery. As a result, the entire system was withdrawn and the distal segment of catheter was accordioned. There was no pushwire damage, and the physician did not attempt to release the slack in the system. A new marksman and pipeline were used to complete the procedure with no issues. Angiographic results post-procedure showed slowed blood flow in the aneurysm. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms were reported. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the c4 with a max diameter of 5mm and a 2mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Ancillary devices include a navien guide catheter, cook long sheath.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10446508
MDR Text Key206580534
Report Number2029214-2020-00832
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 08/24/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-500-25
Device Catalogue NumberPED-500-25
Device Lot NumberA918065
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/21/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-