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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 PED2-475-20
Device Problems Material Deformation (2976); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/20/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that three pipeline stents became twisted and failed to open. The patient was being treated for an unruptured saccular aneurysm. The max diameter was 6mm. The neck diameter was 4mm. The distal landing zone 4. 2mm and the proximal landing zone was 4. 5mm. Vessel tortuosity was moderate. All devices were prepared as according to the instructions for use (ifu).   while introducing pipeline shield 4. 75x35 through marksman microcatheter it was twisted at thebeginning with failure to be straighten after resheathing technique was used it also failed and another stent used with another microcatheter. The failure to open on the pipeline was on the proximal end. After failure to open the first stent another stent 4. 75x20 was introduced through exclesior xt-27 microcatheter the stent was also twisted at its middle part with failure to overcome this twist with resheathing technique. The failure to open was in the middle section. After the failure of the previous two stents this stent pipeline shield 4. 5x35 was introduced through exclesior xt-27 it was twisted from its distal end with multiple failed trials to straighten the stent. The failure to open was on the distal end. The pipelines were not positioned in a bend. They were not stuck in the capture coil. Less then 50% of the pipelines were deployed when it failed to open. The pipelines were resheathed more than 2 times. The pipelines was removed from the patient with the microcatheters.   no symptoms were reported. Dual antiplatelet treatment was administered.   ancillary devices: cordis 8f sheath, guider softip 8f guide catheter , marksman microcatheter, synchro 14 guidewire, exclesior xt-27 microcatheter.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12533890
MDR Text Key273376687
Report Number2029214-2021-01207
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeEG
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 09/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-475-20
Device Catalogue NumberPED2-475-20
Device Lot NumberB047171
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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