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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 PED2-400-12
Device Problems Positioning Failure (1158); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/01/2022
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 upon obtaining access into the right ica with a triaxial approach of the phenom 27 microcatheter in the right mca, the phenom plus positioned distally to the horizontal petrus and the 7fr rist at the level of the horizontal petrus (right ica), the pipeline shield was prepped per fda instructions and delivered into the phenom 27 microcatheter with moderate tortuosity. The pipeline was slightly opened in the right mca then dragged into position of the right supraclinoid aneurysm just distal to the right pcomm but during delivery the pipeline slipped out of position. The physician correctly tried to resheath the pipeline to reposition more distally but the pipeline came off the distal bumper and they lost control of resheathing the pipeline and with about 60% of the pipeline still inside the phenom 27, they were able to completely remove the pipeline by removing the phenom 27 with no complications to the patient. A new phenom 27 and pipeline were prepped per fda instructions with the same scenario as before occurring, the pipeline mispositioned over the aneurysm and the pipeline came off the bumper while attempting to resheath. A third phenom 27 and pipeline were used with no complications and the procedure was successfully completed. The pipeline was not used off-label and was prepared as indicated in the ifu. There were no patient symptoms or complications associated with the event. A dapt (dual antiplatelet treatment) was administered and the pru level was 130. The angiographic result post procedure showed good result. The patient was undergoing surgery for treatment of a amorphous, unruptured aneurysm in the right supraclinoid ica with a max diameter of 5mm and a 3mm neck diameter. It was noted the patient's vessel tortuosity was moderate.
 
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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 Key14606067
MDR Text Key300789866
Report Number2029214-2022-00949
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00763000284329
UDI-Public00763000284329
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018
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 06/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-400-12
Device Catalogue NumberPED2-400-12
Device Lot NumberB318810
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/01/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/06/2022
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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