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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-400-12
Device Problems Break (1069); Detachment of Device or Device Component (2907); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/05/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pipeline was not opening in the distal end.The device was then resheathed and another deployment attempted, which resulted in better distal opening but not perfect.The device was reshseated again and the physician decided to drag and drop the pipeline into the desired ica location.Upon deployment, the physician realized the device was not delivering correctly and that they no longer had control of the device.They attempted to recapture the device but no longer could, resulting in use of an intermediate catheter to retrieve the microcatheter and pipeline.The physician commented that the issue was due to a device fracture at the proximal hypotube.During advancement through the microcatheter resistance was felt in the middle, but no damage to the catheter was seen.The patient was undergoing treatment of an unruptured, saccular right pcomm aneurysm with a max diameter of 6mm and a neck width of 4mm.It was noted that the patient's vessel tortuosity was normal and that the devices were prepared as indicated per the ifu including use of a continuous flush.The patient was ultimately implanted with a stryker flow diverter which was well opposed with no issues.There were no related patient symptoms.
 
Manufacturer Narrative
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.
 
Event Description
Additional information received reported the pipeline was not placed in a vessel bend when the failure to open occurred.The physician noticed resistance upon delivery of the device with two attempts to resheath and delivery of the device upon noticing that physician had no control over the device deployment.
 
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Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
MDR Report Key11680900
MDR Text Key245984125
Report Number2029214-2021-00444
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00847536015814
UDI-Public00847536015814
Combination Product (y/n)N
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/27/2022
Device Model NumberPED-400-12
Device Catalogue NumberPED-400-12
Device Lot NumberA906064
Was Device Available for Evaluation? No
Date Manufacturer Received04/19/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age50 YR
Patient Weight75
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