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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE VANTAGE WITH SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED3-027-450-16
Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/03/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that a ped3 pipeline was stuck in the phenom 27 catheter. The patient was being treated for a ruptured aneurysm. The pipeline was used for an indication of acute usage that is not approved. The devices was prepared as indicated in the instructions for use (ifu). The catheter was flushed continuously with heparinized saline. The pipeline became stuck during deployment. Additional information received reported the lesion was in the left internal carotid artery (ica), multi lobular aneurysm 3 lobes - wide necked small pcom aneurysm due to size and angulation. Vessel tortuosity was severe, proximal leg calcification and stenosis at the common iliac. The patient was recovering fine and was discharged the next day. No symptoms were reported. The resistance was in the distal section of the catheter. It could not re-sheath the device. No damage to the pipeline pushwire or catheter was observed. Physician flared first ped3 stent in m1, dragged back and it fell to far back not covering the neck of aneurysm. Catheter tip would not move when attempting to re sheath, it was also catching the ophthalmic origin. Ped3 4. 5 x 16 stent was removed along with phenom 27. 2nd stent 4. 5x20 opened fine distally, foreshortened a little when recovering delivery system through the stent. Neck of aneurysm is covered by the stent. Physician did not track phenom through the stent as he did not believe it was necessary to do so. Vessel sizing 3. 75mm distal and 4. 4mm proximal.
 
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Brand NamePIPELINE VANTAGE WITH 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 Key13625381
MDR Text Key286578379
Report Number2029214-2022-00327
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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 05/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-450-16
Device Catalogue NumberPED3-027-450-16
Device Lot NumberB242896
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/31/2021
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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