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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-400-14
Device Problems Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported the pipeline (ped-400-14) was inside a catheter in the middle cerebral artery territory to treat an aneurysm of the posterior communicating artery.It was stated when trying to push out the device, it would not open distally so they had to pull the device back.Once the physician pulled the device back far enough to get it to finally open, it was too far proximal to the aneurysm, and with the tortuosity, the physician was not able to advance the pipeline (resheath and advance it) so they pulled the device out.Then with the same phenom, another pipeline (ped-400-16) was used.The physician was able to get the distal end to open, but when trying to place the pipeline, it also pulled back proximal to the aneurysm.The pipeline was unable to be resheathed so the device was pulled out.The physician then used another phenom and pipeline (ped-400-16) that was deployed successfully.There was no pat ient injury as a result of the event.
 
Event Description
Additional information received reported the first device was in the proximal m1 when opening.When it failed it was pulled back into distal ica and still wouldn¿t open.The second device opened in the m1 and when pulled out into ica it came to far back proximal to aneurysm and they couldn¿t resheath the device.There was no friction or difficulty during delivery or positioning.It was noted that the the vessel tortuosity was moderate to severe.It reported that both devices jumped when a little when transitioning from m1 to the ica.The tip of the catheter did not move during deployment.The devices were prepared as indicated in the instructions for use (ifu).
 
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.
 
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 positioning was not in a vessel bend.There was no friction during delivery.It was noted that the patient's vessel tortuosity was moderate.The devices were prepared per the instructions for use (ifu).
 
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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 Key11287748
MDR Text Key230704703
Report Number2029214-2021-00143
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00847536015845
UDI-Public00847536015845
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,Followup
Report Date 06/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/05/2023
Device Model NumberPED-400-14
Device Catalogue NumberPED-400-14
Device Lot NumberB127908
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/03/2021
Initial Date FDA Received02/05/2021
Supplement Dates Manufacturer Received02/05/2021
06/10/2021
Supplement Dates FDA Received02/23/2021
06/16/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
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