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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-250-20
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/11/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that pipeline flex with shield device stuck/lock inside the xt 27 catheter and tip of the pipeline broke. The catheter was damaged. The device was removed intact and did not affect the patient, no injury was reported. The procedure as completed with a replacement product. The patient underwent embolization treatment for an unruptured saccular aneurysm was located cerebral artery. Measuring 4. 6mmx3. 6mm. Landing zone distal 2. 1mm proximal 2. 3mm. The vessel was observed severely tortuous. It was reported that during the procedure and due to the tortuosity of the patient's arteries, the xt27 microcatheter elongated causing the entrapment of the pipeline flex shield flow diverter. Pipeline stuck at the distal section of the catheter. In addition to the tip coil of the diverter it was observed fractured in the fluoroscopy image, which also it prevented the specialist doctor from advancing the device. There were not any patient symptoms or complications associated with this event. No medical or surgical intervention needed to prevent a permanent impairment of a function. The event did not lead or extended patient hospitalization. Dapt (dual antiplatelet treatment) was administered. The pipeline and any accessory devices were prepared as indicated in the ifu. The catheter flushed as indicated in the ifu. No patient injury was reported. The catheter flushed continuously with heparinized saline. Ancillary devices include an xt27 microcatheter. Xt 27 catheter.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
9496801345
MDR Report Key9137894
MDR Text Key168452665
Report Number2029214-2019-00967
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/11/2020
Device Model NumberPED2-250-20
Device Catalogue NumberPED2-250-20
Device Lot NumberA399110
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/07/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/15/2019
Was Device Evaluated by Manufacturer? Yes
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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