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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 PED2-500-20
Device Problems Break (1069); Activation Failure (3270); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Event Description
Medtronic received a report that the pipeline failed to open, experienced resistance during retrieval, and the pushwire broke. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the paraclinoid segment of the left internal carotid artery. The patient's vessel tortuosity was moderate. The access vessel was the femoral artery, which was 2. 0mm in diameter. The landing zone was 4. 8mm distal and 5. 1mm proximal. It was reported that the pipeline did not open distally even after massaging the device. After trying for several minutes and not su cceeding in opening the device, the doctor decided to remove it. When trying to retrieve the device it became stuck in the proximal hub of the microcatheter. When attempting to retrieve the device, the distal shaft of the delivery system broke. There was no damage to the catheter. A continuous flush had been administered.  no further hospitalization or medical surgical interventions were needed, and 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 sofia catheter and marksman microcatheter.
 
Manufacturer Narrative
(b)(6). If information is provided in the future, a supplemental report will be issued.
 
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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 Key13018381
MDR Text Key287013181
Report Number2029214-2021-01622
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeMX
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 03/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-20
Device Catalogue NumberPED2-500-20
Device Lot NumberB044935
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2020
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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