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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 PED2-500-18
Device Problems Break (1069); Activation Failure (3270)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the patient was diagnosed with unruptured, saccular aneurysms of the right internal carotid artery, cavernous, and ophthalmic segments, and they underwent endovascular procedure on (b)(6) 2020, to treat the lesions. It happened that 3 pipeline flow redirecting stents were discarded after the devices failed to be released. The first, a 5 x 18mm pipeline (reference: ped2 - 500-18, lot: a850790), did not open distally as expected, even after attempts to recap the stent with repositioning. In an attempt to remove the device from the marksman microcatheter, it broke inside the microcatheter without us noticing and a second 5 x 20mm pipeline stent (reference: ped2-500-20, lot: a737153) was lost, as it was noticed in time that the same pushed the anterior stent into the patient's middle cerebral artery. The procedure was then interrupted with the removal of the patient's microcatheter and with no safe possibility of "saving" the 5 x 20mm pipeline, they opted for disposal. But still a third pipeline, this time a 4. 75 x 20mm (reference: ped2-475-20, lot: a915540), was passed through a new marksman catheter without again being successful, since the behavior of the stent was exactly the same as of the first. The patient's treatment was only carried out safely and successfully after changing the microcatheter for a 155 cm neuroslider¿ 0. 027 "through which a derivo¿ 5 x 20mm stent (acandis (b)(4)) was passed, in a few minutes, without any type of resistance or difficulty. The doctor indicated that the arterial route was not difficult, and they obeyed all the manufacturer's recommendations for its implantation. It was noted the dapt (dual anti-platelet treatment) was administered. There were no patient symptoms associated with the event. The devices were prepared/flushed as indicated in the ifu.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
7635140379
MDR Report Key11004317
MDR Text Key221480214
Report Number2029214-2020-01300
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,distri
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 09/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED2-500-18
Device Catalogue NumberPED2-500-18
Device Lot NumberA850790
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/03/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/14/2020 Patient Sequence Number: 1
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