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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); Unintended Ejection (1234)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
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 pusher separated from the pipeline, it released early, and phenom 27 microcatheter was crushed. The patient was undergoing treatment for an unruptured, fusiform aneurysm located in the carotid pre-bifurcation communicating segment. The max diameter was 9mm, and the neck diameter was 7mm. The patient's vessel tortuosity was moderate. The landing zone was 3. 45mm distal and 3. 80mm proximal. The access vessel was the internal carotid which was 4mm in diameter.  dual antiplatelet treatment was administered (prasugrel). It was reported that when 40% of the pipeline was unfolded, it was noted that distal to the device there was a shortening from the middle m1 segment to the proximal m1 (almost carotid bifurcation), so the operator decided to resheathe the pipeline. At this time, it was observed how that the pusher guide separated from the device making it impossible to recapture. The physician tried to do usual maneuvers to reposition it, but without having control over the release of the device the operator decided to remove the entire system. Another phenom microcatheter and pipeline were deployed without issue. The device had opened prematurely. There had been no friction/difficulty during the procedure, and the pushwire had not been rotated or pulled back at any time. It was noted that the distal part of the microcatheter was crushed.  the patient did not experience any injury, complications, prolonged hospitalization, or additional medical/surgical interventions. Angiographic results post procedure showed an excluded aneurysm and a patent artery. The devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a shuttle 6fr sheath and an avigo. 014 guidewire.
 
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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 Key12222335
MDR Text Key263443808
Report Number2029214-2021-00916
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAR
PMA/PMN Number
P100018.S026
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 10/18/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2021
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 NumberB101193
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/16/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/13/2020
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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