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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 PED2-500-35
Device Problems Break (1069); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
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 a pipeline experienced resistance in a phenom 27 microcatheter and the proximal part of the pushwire broke. A non-medtronic guidewire also experienced resistance. The patient was undergoing treatment for a basilar fusiform aneurysm. The patient's vessel tortuosity was severe. The access vessel was the femoral artery, which was 4mm in diameter. It was reported that a merit flexor short touhy was used in this case, and the pipeline got stuck in the touhy. They tried to pull the pipeline out, and got the implant out of touhy/phenom 27 catheter hub. Then, a synchro guidewire would not advance through the phenom 27. The 15mm distal of the pipeline pusher wire tip and polyurethane flaps broke off in the phenom 27. It was believed that this was caused by the touhy. The catheter was removed. They tried to advance a wire through the phenom but could not because the pipeline wire tip remained in the catheter. The phenom was cut open and it was confirmed the wire was in the device. A new phenom catheter was used, but they kept the same short touhy and were met with resistance in advancing the pipeline again. They were able to save this pipeline and changed to a normal touhy, and all went fine thereafter.  the patient did not experience any injury or complications. The devices were prepared and flushed according to the instructions for use (ifu). Ancillary devices include a phenom plus guide catheter.
 
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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 Key12516673
MDR Text Key272911694
Report Number2029214-2021-01191
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-35
Device Catalogue NumberPED2-500-35
Device Lot NumberB245482
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/17/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/05/2021
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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