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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-20
Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/03/2021
Event Type  malfunction  
Event Description
Medtronic received a report that the  the patient was undergoing treatment for an unruptured, fusiform complex aneurysm located in the ophthalmic artery segment. The max diameter was 9mm, and the neck diameter was 7mm. The patient's vessel tortuosity was normal. The landing zone was 3. 9mm distal, and 4mm proximal. The access vessel was the femoral artery, which was 6mm in diameter. It was reported that the pipeline was slowly delivered through the y valve, the protective sheath was removed, and the doctor continued to push with great resistance. When the pipeline tip was deployed, it was difficult to open the middle section. After the successful deployment, the rivet adhered to the wall well. They pushed the marksman up and recovered the pipeline guidewire. The recovery was difficult. Repeated adjustments were unsuccessful and the forward push recovery was unsuccessful. The navien also failed to pass the proximal end of the pipeline. The push guide wire could only be withdrawn without being recovered into marksman. In this process, the protective sleeve of the tip of the push guide wire was hooked with the deployed pipeline, and then the stent was also hooked when it was moved forward and then withdrew. There was readjustment and withdrawal, causing the pipeline to fall off into the aneurysm. Observing the marksman catheter in vitro, the soft section at the tip end was accordion-like, and the pipeline protective sleeve at the tip end was stuck at the tip end of the catheter, but the recovery in vitro was still unsuccessful. A new catheter was used and deployed the stent, but they still couldn¿t recover the pipeline push guide wire into the marksman. After adjustment, the catheter and pipeline guide wire were slowly withdrawn as a whole, and then hooked to the pipeline so that the device was retracted for a certain distance and almost fell off again.  the pipeline tip-end protective sleeve could not be resheathed into the marksman, and the material was very hard, so it still could not be resheathed in vitro after withdrawing the stent. The devices were replaced, and the patient did not experience any injury or complications. Angiographic results post procedure showed retention in the aneurysm. The devices were prepared and flushed according to the instructions for use (ifu).
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX
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 Key12759805
MDR Text Key285227003
Report Number2029214-2021-01408
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P100018
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,Followup
Report Date 01/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/07/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-450-20
Device Catalogue NumberPED-450-20
Device Lot NumberB250922
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/15/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2021
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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