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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 PED2-375-20
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that the pushwire and device were disconnected and it was difficult to bring the device back into the mi crocatheter. The healthcare provider wanted to treat a ruptured, blister like aneurysm of the left ica. They used a neuron max sheath and a phenom plus catheter to navigate into the ica. Then, they passed the artery with a headway 27 microcatheter. They prepared the pipeline shield flow diverter as described in the ifu. The pipeline ran up without muchfriction. The distal opening also proceeded without any problems. After 1/3 was released, the physician wanted to resheath the device, which led to the difficulty bringing the device back into the microcatheter. The system was removed, and a phenom plus and the headway was placed back into the vessel and implanted a pipeline without any problems. The pushwire was not rotated during removal. The catheter was not damaged, nor was the pushwire damaged. The capture coil was not damaged during removal. A dapt (dual antiplatelet treatment) was administered and the pru level was unknown. The angiographic result post procedure showed after the second flow diverter - stasis. The patient was undergoing surgery for treatment of a blister-like, ruptured aneurysm with a max diameter of 2. 5mm and a 3mm neck diameter. It was noted the patient's vessel tortuosity was moderate. Ancillary devices include: a neuron max, a phenom plus, a headway 27, and a traxcess 14.
 
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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 Key13057434
MDR Text Key286887460
Report Number2029214-2021-01649
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-375-20
Device Catalogue NumberPED2-375-20
Device Lot NumberB174352
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/29/2021
Is the Reporter a Health Professional? No
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/12/2021
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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