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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 11/01/2020
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Baker c, grandhi r, griessenauer cj, et al. Pipeline embolization in patients with posterior circulation subarachnoid hemorrhages: is takotsubo cardiomyopathy a limiting factor? world neurosurgery. 2020;143:e523-e528. Doi:10. 1016/j. Wneu. 2020. 08. 013. Medtronic literature review found a report of that reviewed posterior circulation subarachnoid hemorrhage (sah) patients treated with the pipeline embolization device (ped) in the acute setting and assessed the incidence of takotsubo cardiomyopathy (tcm). A total of 23 patients (9 male, 14 female) underwent ped placement in the acute setting as treatment for posterior fossa sahs during the study period. The patients ranged in age from 24 to 75 years (median 55 years). The article does not state any technical issues during use of the pipeline. Ninety-one percent of patients had complete or near-complete aneurysm occlusion on follow-up imaging, and 16/18 survivors had a favorable outcome. The majority of surviving patients had a favorable mrs at follow-up: 15 of 23 patients (65%) had an mrs score of 0. The following intra- or post-procedural outcomes were noted: - 5 patients died in the perioperative period (22%), 4 during their hospital stay and 1 within 6 months. - 3 of the 23 (13%) patients were diagnosed with takotsubo cardiomyopathy (tcm). All patients with tcm had an ejection fraction on transthoracic echocardiogram that was consistent with cardiac failure. - 1 patient experienced neurogenic pulmonary edema and was intubated but recovered. - 4 patients had a stroke on follow-up imaging; 2 of these were symptomatic and 2 were asymptomatic. - 2 of 23 patients (9%) required retreatment: 1 with an additional ped and another with ped and subsequent open clip placement - 2 patients had intraparenchymal hemorrhage on follow-up imaging; 1 of these lesions was symptomatic.
 
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Brand NamePIPELINE
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 Key10980845
MDR Text Key220624296
Report Number2029214-2020-01278
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 12/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/09/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/13/2020
Was Device Evaluated by Manufacturer? No Answer Provided
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: 12/09/2020 Patient Sequence Number: 1
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