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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-475-12
Device Problem Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2022
Event Type  malfunction  
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
Medtronic received a report that the device was positioned properly and the distal segment was beginning to flow open. When attempting to move the catheter and ped proximal to the appropriate landing zone, the system jumped proximal to the anz. The physician was unable to navigate the ped back to an appropriate location distal to fully cover the anz neck. The ped was removed and a 4. 75x14 was successfully implanted. There was movement during placement. There were not multiple pipeline devices being used when the movement occurred. There was minimal friction during delivery or positioning. The pipeline was not implanted at the intended location. The pipeline missed the landing zone. The device did jump during the deployment. The pipeline was placed at least 3mm past the aneurysm neck on each side. The side branch was not covered by pipeline. The tip of the catheter was moved during the deployment. The device was not used off-label and was prepared as indicated in the ifu. There were no patient symptoms or complications associated with the event. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right ica with a max diameter of 8mm and a 4mm neck diameter. It was noted the patient's vessel tortuosity was severe. Adapt was administered but the pru level was unknown. The angiographic result post procedure showed the ped fully covered the anz with only partial contrast filling present.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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
glen belmer
9775 toledo way
irvine, CA 92618
6122713209
MDR Report Key14741357
MDR Text Key302579420
Report Number2029214-2022-01024
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00763000284596
UDI-Public00763000284596
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 06/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-12
Device Catalogue NumberPED2-475-12
Device Lot NumberB335217
Was Device Available for Evaluation? No
Date Manufacturer Received06/13/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/08/2022
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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