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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 PED2-475-25
Device Problems Positioning Failure (1158); Component or Accessory Incompatibility (2897); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/22/2019
Event Type  malfunction  
Manufacturer Narrative
It was reported that the 1st pipeline (ped2-475-25) had problems opening up and had resistance during delivery. Additional information was required to determine the cause of the event. The hcp was contacted for clarification on the event and response was received. As the device had been disposed of, no analysis could be performed. There was no indication that the event was related to a potential manufacturing issue and no dhr was requested, so a device history record review was not performed. The ifu states: "do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. " placing the device on a bend may contribute to device having problems opening. ¿caution: if high forces or excessive friction is encountered during delivery, discontinue delivery of the device and identify the cause of the resistance, remove device and micro catheter simultaneously. Advancement of the pipeline¿ flex embolization device with shield technology against resistance may result in damage or patient injury. ¿ the investigation determined that this was a known event, and therefore no new formal investigation was required. Common sequences of events and contributing factors that can lead to this known event are documented in the risk management file. Reference mdr# 2029214-2019-00560. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the first medtronic flow diverter (this reported device) did not open properly on the distal end and took a long time to open and a second medtronic flow diverter was implanted to telescope the distal end because they could not place the first pipeline at the precise location. The second flow diverter was also stated to not have opened correctly. The physician complained that both flow diverters were not visible on the screen of the siemens angiosuite. After the flow diverters were implanted, the inr did a post dilation to make sure the devices were completely open and also inserted more coils in the aneurysm. No patient injury was reported as a result of the event. The patient was undergoing embolization treatment of an unruptured amorphous aneurysm with a neck of 7mm located in the internal carotid artery (ica). The patient¿s vasculature was severe in tortuosity. Ancillary devices: microvention cosmos coils, terumo 16 guidewire, headway 27 microcatheter, fargo max 6f sheath.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8700818
MDR Text Key148169465
Report Number2029214-2019-00559
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-25
Device Lot NumberA766245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured01/14/2019
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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