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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 PED2-375-18
Device Problems Positioning Failure (1158); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/18/2020
Event Type  malfunction  
Manufacturer Narrative
H3: the pipeline flex embolization device and marksman catheter were returned for analysis. The pipeline flex embolization device was returned within the marksman catheter. The pipeline flex pusher was found protruding from within the marksman catheter hub for ~47. 6cm. The marksman catheter body was found accordioned at ~37. 0cm, 26. 5m, 22. 0cm, 20. 0cm and from ~7. 5cm to ~4. 0cm from the distal tip. The pipeline flex braid was found partially deployed from within the marksman distal tip. The pipeline flex embolization device was pushed out from within the marksman catheter with some resistance. The pipeline flex pusher was found intact. The pipeline flex resheathing pad and marker were found in good condition. The pipeline flex braid proximal end was found open and in good condition. The pipeline flex braid distal end was found opened, but damaged (frayed). The distal core wire was found broken at ~4. 2cm from the proximal bumper. The ptfe sleeves and tip coil were found missing and not returned. The broken wire was sent out for sem (scanning electron micrographic) analysis. Per the analysis report, the wire end exhibits significant corrosion and no original fracture features are visible. No other anomalies were observed. Based on the device analysis and reported information, the customer¿s report of ¿difficult placement/positioning¿ and ¿ped stuck on dps¿ could not be confirmed. It is possible the damage found with the pipeline flex braid contributed to the event; however, the cause could not be determined. Regarding the broken pusher, this event is similar to events that had already been investigated, and another investigation is not necessary. Based on the formal investigation conducted, pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity. However, the cause could not be determined. 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 pipeline was very heavy to be browsed. During the second recovery attempt, the pipeline was not allowed maneuvers to impossibilitate the correct positioning. When removing the pipeline and marksman assembly, it was noticed that a sleeve was not opened. A new marksman and pipeline were then used to complete the procedure satisfactorily. It was indicated that all devices were prepared and flushed as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Post-procedure angiographic results were satisfactory. The patient was undergoing surgery for treatment of a saccular, unruptured aneurysm of the right internal carotid artery back commun icating segment with a max diameter of 10 mm and a 6 mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Dual antiplatelet therapy (dapt) was administered, and the platelet reactivity units (pru) level was unknown. Ancillary devices include a terumo sheath, neuron guide catheter, avigo guidewire, hyperglide, axium coils.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key11197815
MDR Text Key227781571
Report Number2029214-2021-00066
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial
Report Date 01/19/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-375-18
Device Catalogue NumberPED2-375-18
Device Lot NumberA906073
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/17/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2019
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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