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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 PED2-275-16
Device Problems Activation, Positioning or Separation Problem (2906); Unintended Movement (3026)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2022
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 phenom 27 microcatheter was advanced beyond the neck of the aneurysm, subsequently the flow diverter was fully deployed without any complication. An angiographic control was performed where it was observed that the diverter was adequately open and covering the neck of the aneurysm. The distal guide of the diverter and the microcatheter were recovered and removed without any problem. When giving fluoroscopy to perform angiographic acquisition, shortening of the device was observed, the remaining of the diverter in the neck of the aneurysm, for which it was necessary to implant another flow diverter. There were not multiple pipeline devices used when the movement occurred. There was no friction or difficulty during delivery or positioning. The pipeline was implanted at the intended location and missed the landing zone, thus the second diverter being implanted. The device did not jump during the deployment. The pipeline was placed at least 3 mm past the aneurysm neck on each side. The lenticulostriate side branches covered by the pipeline. The cause of the movement was not known. Full wall apposition was achieved. 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. A dapt was administered but the pru level was not known. The angiographic result post procedure showed a satisfactory final result. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm in the right middle cerebral artery with a max diameter of 5. 02 mm and a 4. 3 mm neck diameter. It was noted the patient's vessel tortuosity was minimal. Ancillary devices include: 8fr sheath, sofia 6fr distal access catheter, phenom 27, and traxcess guidewire.
 
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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 Key14805980
MDR Text Key302336147
Report Number2029214-2022-01060
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 08/24/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-275-16
Device Catalogue NumberPED2-275-16
Device Lot NumberB211340
Was Device Available for Evaluation? No
Date Manufacturer Received08/10/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/25/2021
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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