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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 PED3-027-500-14
Device Problems Unintended Movement (3026); Activation Failure (3270)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Manufacturer Narrative
See manufacturer report # 2029214-2022-00232 for the other pipeline involved in this event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a report that a pipelines failed to open proximally, and a replacement pipeline failed to open distally. The patient was undergoing treatment for an unruptured, saccular aneurysm located in the paraophthalmic artery. The max diameter was 6mm, and the neck diameter was 5mm. The patient's vessel tortuosity was normal. The landing zone was 3. 3mm distal and 5. 1mm proximal.  dual antiplatelet treatment was administered. It was reported that navigation was straight forward, and the device was navigated to the desired location. The patient's anatomy was normal. The distal end of the first pipeline was flared proximal to the posterior communicating artery (pcom). The device opened around the cavernous bend with loading and unloading the entire system. The stent was long and the physician claimed there was a twist as the stent came into the cervical ica. Repeated attempts to untwist this section was unsuccessful, and the device was replaced. A shorter pipeline was used, but this time the distal end of the stent did not fully appose while the mid-section was well apposed. The physician attempted to load and unload the entire system, which caused the distal end of the device to fall back and miss the landing zone. The pipeline jumped, and had been placed at least 3mm past the aneurysm neck on each side. No side branches were covered, and the tip of the catheter was moved during deployment. The second pipeline was also removed.  the case was abandoned, but patient did not experience any injury or complications.  the proximal and distal part of the first pipeline was positioned in a bend, and the distal part of the second pipeline was positioned in a bend when they failed to open. More than 50% had been deployed when they failed to open. The pipelines were resheathed 2 or less times, and no other steps were taken to open the device. There had been no friction or difficulty during delivery or positioning.  the devices were prepared according to the instructions for use (ifu). Ancillary devices include a 7f short sheath, rist 079 guide catheter, sofia 5f guide catheter, and a phenom 27 microcatheter.
 
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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 Key13550917
MDR Text Key294666804
Report Number2029214-2022-00233
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,Followup
Report Date 03/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/17/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED3-027-500-14
Device Catalogue NumberPED3-027-500-14
Device Lot NumberB229656
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/02/2021
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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