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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-350-35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intracranial Hemorrhage (1891); Neurological Deficit/Dysfunction (1982)
Event Type  Injury  
Manufacturer Narrative
The device was not returned for analysis. The reported events are known inherent risk of endovascular procedure and are documented in our device¿s instruction for use (ifu). Based on the reported information, there is no evidence suggesting that the device was defective, but rather a post procedure and patient condition related events. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received the following adverse event through literature review of ¿giant vertebrobasilar dissecting aneurysms in pediatric patients¿ (jiejun wang, yisen zhang, ming lv, xinjian yang, zhongbin tian, jian liu, peng liu, zefeng miao, luqiong jia, junfan chen, xinghuan ding, ying zhang, wei zhu, wenqiang li, kun wang and zhongxiao wang) 54 patients agreed to undergo ped therapy. Of these 54 patients, four were 18 years old or younger at the time of presentation (two males, and two females; mean age 9. 25 years; age range 8¿11 years). Case 3: an 8¿10-year-old patient with a mrs of 2 experienced a sudden onset of headaches accompanied by dysphagia 2 months before being admitted to our hospital. Cta performed in another hospital revealed a giant dissecting aneurysm located in the vbj, which was confirmed on dsa performed in our hospital. The lva was treated with two peds (3. 5 × 35mm), and the rva underwent parent artery occlusion with coils. Immediately postoperative angiography showed excellent reconstruction of the lva, and complete occlusion of the rva. After the procedure, the clinical symptoms were mildly improved compared with preoperatively. One day post-treatment, mri demonstrated a giant mass effect with an intramural hematoma, resulting in severe brainstem compression. Six months post treatment, follow-up dsa revealed complete occlusion of the lva and rva. Compared with mri performed at 1 day post-treatment, follow-up mri showed a marked reduction in the mass effect. At 6 months after the procedure, the patient had no clinical problems and/or focal neurological function deficiency, with a mrs of 0. As this patient had weak dual posterior communicating arteries preoperatively, the good clinical outcome might be attributed to the presence of robust dual posterior communicating arteries after the procedure.
 
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Brand NamePIPELINE FLEX
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
katcha taylor
9775 toledo way
irvine, CA 92618
7635263305
MDR Report Key8768865
MDR Text Key150409090
Report Number2029214-2019-00691
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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 07/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-350-35
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 Received06/13/2019
Was Device Evaluated by Manufacturer? No
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: 07/08/2019 Patient Sequence Number: 1
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