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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 PED2-450-20
Device Problems Positioning Failure (1158); Material Deformation (2976); Unintended Movement (3026); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/11/2021
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 there was movement/difficulty during delivery of the pipeline and it failed to open distally. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the left paraophthalmic artery. The max diameter was 6. 3mm, and the neck diameter was 5mm. The patient's vessel tortuosity was moderate. The landing zone was 4mm distal and 4. 3mm proximal. The access vessel was the left internal carotid, which was greater than 6mm in diameter.  dual antiplatelet treatment was administered.  patient medical history included arterial hypertension. It was reported that during the appositioning of the device, the pipeline did not open distally and when it was released more it twi sted.  the doctor tried several times to reposition it without being possible, so they decided to remove it with the microcatheter the middle part of the pipeline had been positioned in a bend, and more than 50% had been deployed when it failed to open. The physician had resheathed the pipeline 2 or less times, and no other steps were taken to open the device. There had been movement during pla cement. Only the single pipeline was being used when the movement occurred. The pipeline missed the landing zone. The device did not jump during deployment, and the pipeline had been placed at least 3mm past the aneurysm neck on each side. No side branches were covered by the pipeline. The tip of the catheter did not move during deployment.  there had been minimal friction/difficulty during delivery or positioning.  the pipeline and catheter were removed from the patient and replaced.  the event did not lead to an extended hospitalization. Angiographic results post procedure were satisfactory, uncomplicated, and showed adequate redirecting effect.  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 marksman microcatheter, boston 8fr sheath, chaperon 6fr guide catheter, and traxcess 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 Key11825725
MDR Text Key251195645
Report Number2029214-2021-00574
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
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,Followup
Report Date 12/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-450-20
Device Catalogue NumberPED2-450-20
Device Lot NumberB092244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/26/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/25/2020
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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