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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 PED-425-12
Device Problems Break (1069); Positioning Failure (1158); Activation, Positioning or SeparationProblem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/09/2020
Event Type  malfunction  
Manufacturer Narrative
Device evaluation anticipated, but not yet begun. A supplemental report will be submitted. Linked with mdr: 2029214-2020-00210. If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the previous pipeline (pli20) implanted one year prior showed residual aneurysm. A new pipeline (pli10) was implanted, but experienced resistance during delivery. The new pipeline was successfully delivered with a slight incomplete apposition of the distal segment. It was indicated there was difficult placement/positioning. A synchro 14 wire with a j-curve was advanced to the distal segment of the pipeline, and the tip of the wire appeared inside the marksman microcatheter. The marksman was removed from the patient and flushed on the table revealing the distal tip of the wire had fractured at the junction on the weld joint. A microvention septer c balloon was advanced and dilated which successfully completed apposition of thedistal segment of the pipeline. It was indicated that all devices were prepared as per the instructions for use (ifu), and no patient symptoms or further complications were reported as a result of this event. Ancillary devices include a phenom microcatheter, marksman microcatheter, fubuki sheath, microvention balloon, synchro 14 guidewire. Additional information: the previously implanted pipeline model and lot numbers are (initial treatment date: (b)(6) 2018), ped-425-25, lot# a251741. Patient information is (lk), dob: (b)(6) 1962, weight: (b)(6) kg, female. The aneurysm was in left internal carotid artery (ica), ophthalmic segment. Aneurysm 2 mm x 3 mm. The vessel tortuosity was moderate. No images are available. The resistance was distal section. Feature of distal tip coil of pipeline not noticed until post deployment of pipeline and advancement of scepter balloon to post dilate. Distal tip coil was always completely encapsulated in the microcatheter, without complication to patient. The resistance was felt within the 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 Key9903499
MDR Text Key190318237
Report Number2029214-2020-00310
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
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,Followup
Report Date 05/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-425-12
Device Lot NumberA830304
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/29/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/31/2020 Patient Sequence Number: 1
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