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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 PED2-250-10
Device Problems Unintended Movement (3026); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/25/2021
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 pipeline moved during placement and was difficult to advance through the marksman catheter. The catheter was also difficult to navigate. The devices were replaced, and the same issues occurred with a second pipeline and marksman. A third device was successfully implanted, and the patient did not experience any injury or complications. No further medical/surgical interventions or hospitalization was needed. Angiographic results post procedure showed that the pipeline was implanted correctly, and the distal brain flow was preserved. The patient was undergoing treatment for a ruptured aneurysm located in the a2 segment of the right anterior cerebral artery. The max diameter was 3mm, and the neck diameter was 2mm. The access vessel was the right femoral artery. Ancillary devices include a catalyst guide catheter, traxcess guidewire, and guidewire hybrid. Technique: patient under general anesthesia, performed right femoral puncture, with the placement of a short bf introducer through which the neuromax 088 long sheath passed, aided by a 0. 035x180cm hydrophilic guide for preliminary angiographic study. Sequentially, a long sheath is positioned in the petrous segment of the right internal carotid artery. Then, through a coaxial system formed by catalyst intermediate catheter, marksman microcatheter (3 units) on traxess 0. 014 micro guide (2 units) and hybrid 0. 008 microglia, microcatheterization of the distal segment of the right anterior cerebral artery was performed. An attempt was made to release the 2. 5x10 pipeline stent (ref ped2-250-10; lot b127864) and 2. 50x12 pipeline stent (ref ped2-250-10; lot b143786), without success due to failure in navigability within the microcatheter, making it impossible to the advancement of the stent to the arterial lumen. Sequentially, through a new set formed by a marksman 27 microcatheter and a 2. 75 x 12 mm pipeline stent (lot b125279), the stent adjacent to the aneurysmal neck was released without complications. Control cerebral angiography was performed, which showed an adequately positioned stent and preserved distal arterial flow. Chemical angioplasty was performed with 10mg of milrinone. The sheath was removed in the room and an angioseal 6f arterial sealer was implanted in the right common femoral artery. Result: presence of an irregular saccular aneurysm in the pericallosal artery, a branch of the right anterior cerebral artery, measuring approximately 2x2mm. After the procedure, proper placement of the flow-diverting stent over the aneurysmal neck was observed, with preserved distal cerebral flow. Absence of cerebral vasospasm. Other intracranial arterial branches without abnormalities. Habitual superficial and deep venous return in left anterior and posterior circulation. Free carotid bulbs. Conclusion: endovascular treatment of aneurysm in the right pericallosal artery with the implantation of a flow-diverting stent.
 
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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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12449200
MDR Text Key271129694
Report Number2029214-2021-01144
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeBR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 09/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/09/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-250-10
Device Catalogue NumberPED2-250-10
Device Lot NumberB127864
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/25/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/05/2020
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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