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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE; INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number NV UNK PIPELINE
Device Problem Activation Failure (3270)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 06/16/2021
Event Type  malfunction  
Event Description
Gündogmus, c.A., sabet, s., baltacioglu, n.A., türeli, d., bayri, y., & amp; baltacioglu, f.(2021).Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology, 159101992110307.Https://doi.Org/10.1177/15910199211030780 summary: internal carotid artery (ica) aneurysms constitute 30% of all intracranial aneurysms and are ever more frequently diagnosed thanks to the ubiquitous use of magnetic resonance imaging.Due to these inherently large and wide-necked aneurysms, endovascular treatment of ica aneurysms is exceptionally troublesome and has high recurrence rates even with stent-assisted coil embolization techniques.Identified events: device deployment failure in two embolization devices.One of the pipeline devices that failed to deploy was due to the pipeline not expanding and was being treated for a cervical loop.The patient was treated with adequate ipsilateral flow from the contralateral ica and posterior circulation.The patient recovered from anesthesia without any neurologic sequela.The aneurysm was occluded along with the parent artery.One patient presented with subarachnoid hemorrhage due to rupture of index aneurysm on the 10th -day after flow diversion with ped.Dsa revealed the distal end of the stent migrated proximally and re-diverted flow into the aneurysm sac and led to bleeding.However, this also remodeled the aneurysm neck, allowing the coiling of the aneurysm while maintaining ica patency.The patient was discharged without sequelae additional event information: pipeline embolization device (ped; ev3 neurovascular, irvine, ca).Fifty-four patients (39.1%) were diagnosed incidentally, whereas 49 patients (35.5%) presented with headache, 11 patients (8%) with subarachnoid hemorrhage due to ruptured index aneurysm, one patient (0.7%) with subarachnoid hemorrhage originating from a different aneurysm, 14 patients (10.1%) with cranial nerve dysfunction, and nine patients (6.5%) with neurologic deficits such as hemiparesis and paresthesia.In 19 patients, one flow diverter was used to treat two aneurysms; in two patients, one device was used to treat three aneurysms; and one patient had six adjacent aneurysms covered using a single device.In addition, one patient who was initially treated with ped required two additional peds to be deployed telescopically due to early spontaneous rupture of the treated aneurysm.In another patient, treatment of a bleeding blister aneurysm called for the deployment of three ped devices telescopically during the same session.Additional coiling was used in treatment of 17 patients.
 
Manufacturer Narrative
Gündogmus, c.A., sabet, s., baltacioglu, n.A., türeli, d., bayri, y., & amp; baltacioglu, f.(2021).Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms.Interventional neuroradiology, 159101992110307.Https://doi.Org/10.1177/15910199211030780.This value is the average age of the patients reported in the article as specific patients could not be identified.This value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified.Please note that this date is based off of the date that the article was accepted for publication as the event dates were not p rovided in the published literature.It was not possible to ascertain specific device information from the article or to match the events reported with previously reported events.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events associated regulatory report: 2029214-2022-00304.If information is provided in the future, a supplemental report will be issued.
 
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Brand Name
PIPELINE
Type of Device
INTRACRANIAL 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 Key13602697
MDR Text Key286578738
Report Number2029214-2022-00305
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Other
Type of Report Initial
Report Date 02/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/28/2022
Initial Date FDA Received02/25/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age52 YR
Patient SexFemale
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