• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Paresis (1998); Transient Ischemic Attack (2109)
Event Date 07/07/2020
Event Type  Injury  
Manufacturer Narrative
Moubark, m. , allah, a. Ek. A. , yosef, h. Et al. Flow diverter devices in the treatment of posterior communicating artery aneurysms: mid-term clinical and radiological outcomes. Egypt j radiol nucl med 51, 118 (2020). Https://doi. Org/10. 1186/s43055-020-00241-y. Patient age: this value is the average age of the patients reported in the article as specific patients could not be identified. Sex: this value reflects the gender of the majority of the patients reported in the article as specific patients could not be identified. Event date: please note that this date is based off of the date of publication of the article [or the date that the article was accepted for publication] as the event dates were not provided in the published literature. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Moubark, m. , allah, a. Ek. A. , yosef, h. Et al. Flow diverter devices in the treatment of posterior communicating artery aneurysms: mid-term clinical and radiological outcomes. Egypt j radiol nucl med 51, 118 (2020). Https://doi. Org/10. 1186/s43055-020-00241-y medtronic literature review found reported of patient complications in association with treatment of posterior communicating artery (pcom) aneurysms by flow diverter (fd) devices. The purpose of this article was to assess the pipeline angiographic efficacy (complete aneurysm occlusion) and related complications. The authors reviewed 47 cases of patients treated for pcom aneurysms using a pipeline flow diverter stent. Of the 47 patients, the average age was 51 years, 40 were female and 7 were male. Procedure-related complications occurred in five (10. 6%) patients (two ischemic events, two transient ischemic attack (tia), and one ipsilateral distal hemorrhage) and resulted in persistent neurological morbidity in two (4. 2%) patients. The following intra- or post-procedural outcomes were noted: 1. Hemorrhagic complications occurred in one patient who developed ipsilateral distal hemorrhage <(><<)> 24 h after the procedure, and the last modified rankin scale (mrs) score of 2. 2. Ischemic complications occurred in two patients. One patient with large sized aneurysm (19. 5 mm) was treated with two ped stents which occluded 6 months after primary treatment with an ipsilateral infraction; the patient developed contralateral hemiplegia with last mrs 3. Another patient suffered from ischemic complications secondary to an intra-procedure event in terms of a failure of proper release of ped stent in the treatment of a small-sized (9 mm) aneurysm with ipsilateral ica occlusion and immediate post-operative hemiplegia with last mrs 3. 3. Transient ischemic attacks occurred in two patients. One patient harboring giant aneurysm treated by two ped stents with adjuvant coiling developed transient contralateral hemiplegia 1 month after treatment which completely resolved with last mrs 0. Another patient with large sized aneurysm 13. 8mm treated by single ped stent with last mrs 0. 4. Retreatment was necessary for two un-occluded aneurysms that were retreated at 6th and 12th months after the primary treatment respectively.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10973375
MDR Text Key220660451
Report Number2029214-2020-01261
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 12/08/2020
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
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 Received11/18/2020
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
-
-