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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, Positioning or SeparationProblem (2906)
Patient Problem Vasoconstriction (2126)
Event Date 05/26/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Linfante, i. , andreone, v. , ravelo, n. , starosciak, a. K. , arif, b. , shallwani, h. , tze man kan, p. , mcdermott, m. W. , dabus, g. (2020). Endovascular treatment of giant intracranial aneurysms. Cureus, 12(5), e8290. Https://doi. Org/10. 7759/cureus. 8290 abstract objective: giant intracranial aneurysms (gias) are associated with a high risk of rupture and have a high mortality rate when they rupture (65-100%). The traditional microsurgical approach to secure these lesions is challenging, and as such endovascular embolization has been increasingly selected as a treatment option. Methods: we performed a retrospective analysis of consecutive patients with ruptured and unruptured gias at three medical centers from october 2008 to april 2016. Clinical follow-up and digital subtraction angiography were conducted at six months post-treatment. Chi-square analysis was used to determine differences in outcomes between anterior and posterior circulation aneurysms and if a pipeline embolization device (ped) provided favorable outcomes in unruptured gias. Results: a total of 45 consecutive patients (mean/median age
=
57/59; range: 16-82 years) were included. The mean/median aneurysm size was 29. 9/28. 3 mm (range: 25-50 mm). Eight (18%) patients presented with aneurysmal subarachnoid hemorrhage and 37 (82%) with unruptured gias. Twenty-eight (62%) were treated with a ped: 11 (24. 4%) with one ped, 1 (2. 2%) with ped + coils, 11 (24. 4%) with more than one ped, and 5 (13. 5%) with multiple ped + coils. The overall mortality rate was 3/45 (6. 7%). No deaths were procedure-related. Five (11. 1%) patients experienced ischemic stroke but only 2 had a 90-day modified rankin scale (mrs) score of
=
3. Of 33 patients available for six-month angiography, raymond scale (rs) scores were 1, 2, and 3 for 23/45 (70%), 7/45 (20. 9%), and 3/45 (9. 1%), respectively. Chi-square test demonstrated that overall, anterior circulation gias had better clinical (mrs score) and radiographic (rs score) outcomes than posterior gias. Ped alone provided similar clinical mrs outcomes but had a higher rate of complete occlusion at six months compared with ped + coils and coils alone in unruptured gias (p < 0. 05). Conclusions: endovascular embolization using ped or ped + coils appears to be a moderately safe and effective treatment option for patients with gias. It was reported that in one case at the three month follow-up it was observed that there was foreshortening of the ped braid into the aneurysm. The patient's baseline mrs was 3 and mrs remained a 3 at that three month follow-up. A follow-up procedure was completed to implant a second ped to address the issue and the patient's condition had improved at 9 month follow-up with mrs of 1.
 
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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 Key11017257
MDR Text Key225569494
Report Number2029214-2020-01315
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberNV UNK PIPELINE
Device Catalogue NumberNV UNK PIPELINE
Device Lot NumberNOT-RPT
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 Received12/16/2020
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: 12/16/2020 Patient Sequence Number: 1
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