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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-500-18
Device Problems Deformation Due to Compressive Stress (2889); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/05/2018
Event Type  malfunction  
Manufacturer Narrative
The device has been returned and evaluation is in progress. A follow-up mdr will be submitted when the investigation is complete. Suspect medical device brand name: pipeline flex with shield technology model number: ped2-500-18 mdrs related to this event: this report and 2029214-2018-00621. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the middle part of one pipeline embolization device (ped) and the proximal part of another ped of the same size did not fully open. It was confirmed that the device and all of its accessory devices were prepared according to their indications for use (ifu) and were not used for an indication that is not approved (off-label). The saccular aneurysm location was noted as "anterior circulation" and its status was "unruptured". It was reported that 50% of the middle section of a pipeline embolization device (ped) did not fully open as kinking occurred. The device was used with an unknown guide catheter, unknown microcatheter, and a phenom 27 guidewire. It was also noted that the proximal end of the device was placed in a bend and it was not suck in the capture coil. The product was resheathed twice and then redelivered, but the issue remained ongoing so it was replaced with another ped of the same size. The new ped opened at the distal and middle part, but not in the proximal part; the product was again replaced. There was no known impact or consequence to the patient. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex shield braid was returned detached from the pushwire; therefore, the distal and proximal ends of the braid were unable to be identified. The pipeline flex shield braid appeared fully opened with moderately fraying at both ends. No other anomalies were observed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It is unknown if the second pipeline would have opened if the physician would have detached the device. It was noted that it looked like the proximal part was not going to open up so they did not detach it. The cause of the issue was unknown. The patient anatomy was not tortuous. There was no known impact or consequence to the patient. No further complications were reported/anticipated.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
9775 toledo way
irvine CA 92618
Manufacturer Contact
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7688907
MDR Text Key114617039
Report Number2029214-2018-00620
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup,Followup
Report Date 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/15/2019
Device Model NumberPED2-500-18
Device Catalogue NumberPED2-500-18
Device Lot NumberA344078
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/08/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2016
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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