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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 Problems Activation, Positioning or Separation Problem (2906); Unintended Movement (3026); Migration (4003)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/20/2021
Event Type  malfunction  
Event Description
Jee t, yeon j, kim k, kim j, hong s, jeon p.Early clinical experience of using the surpass evolve flow diverter in the treatment of intracranial aneurysms.Neuroradiology.(2021) 64:343¿351.10.1007/s00234-021-02793-w the purpose of this article was to presented the early experience with flow diversion procedures using the surpass evolve flow diverter (se, stryker) and reported the feasibility and safety profile compared to those of a control group treated with other types of flow diverters.Included were 31 and 53 consecutive flow diversion procedures performed using the se and other commercial flow diverters, respectively, to treat intracranial aneurysms at our institution.We used two commercial flow diversion systems in the comparison group: the pipeline embolization device and surpass streamline.In the se group, technical failures occurred in three (9.7%) cases, due to either incomplete wall apposition or stent migration (n=2, 6.5%).Major complications occurred in four (12.9%) cases: delayed rupture of the target aneurysm (n=1, 3.2%), major ischemic stroke (n=1, 3.2%), sudden death from an unidentified cause (n=1, 3.2%), and parent artery occlusion with stent thrombosis (n=1, 3.2%).Balloon angioplasty was performed in eight (25.8%) cases.On post-procedure mri, a dwi-positive lesion was detected in three (9.7%) cases.After multivariate adjustment, the se group was independently associated with less procedural time of=90 min.The following intra- or post-procedural outcomes related to the medtronic pipeline were noted: 1.Hemorrhage, delayed riph 2.Hemorrhage, delayed rupture 3.Major ischemic stroke, embolic 4.Major ischemic stroke, stent thrombosis 5.All stent thromboses.
 
Manufacturer Narrative
Jee t, yeon j, kim k, kim j, hong s, jeon p.Early clinical experience of using the surpass evolve flow diverter in the treatment of intracranial aneurysms.Neuroradiology.(2021) 64:343¿351.10.1007/s00234-021-02793-w b3 is the age the article was accepted, as no event date was provided.A2 58 years is the average age of the patients who used pipeline devices in the study.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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 Key14069101
MDR Text Key298591239
Report Number2029214-2022-00603
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeKS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 04/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
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
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/16/2022
Initial Date FDA Received04/09/2022
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 Age58 YR
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