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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
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hematoma (1884); Paresis (1998)
Event Date 05/01/2019
Event Type  Injury  
Manufacturer Narrative
Since the device was not returned, we are unable to perform further root cause analysis and the exact cause of the reported event is unknown. All devices are 100% tested and all products are 100% inspected for damages and irregularities during manufacture. No corrective action. Monitoring and trending this type of event. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Neurol india. 2019 may-jun;67(3):797-802. Doi: 10. 4103/0028-3886. 263195. ¿single centre experience of flow diverter treatment of complex intracranial aneurysms from south india: intermediate and long-term outcomes. ¿ santhosh k kannath, aneesh mohimen, kapilamoorthy t raman, mathew abraham1, suresh nair1, jayadevan e rajan. The procedure was successfully completed in 11 patients, and in 2 patients, embolization was abandoned due to the inaccessibility of delivery microcatheter beyond the aneurysm into the distal parent artery. Ped was deployed in 8 patients and fred in 3 patients. A total of 12 peds were deployed, 1 each in 6 patients and 3 in two patients. No significant technical issues were noted in the patients treated with a single ped. In patients treated with multiple peds, the loss of distal arterial access after deployment of the first or second device resulted in prolongation of treatment duration. Among the fred cohort, inadequate opening of the device and inability to introduce the device through the recommended catheter resulted in the use of additional fred in two patients. The artery distal to the aneurysm was accessed by marksman catheter (for pipeline embolization device, ped, covidien, us) or headway 27 (for flow restoration embolization device, fred, microvention, tustin, us). Periprocedural complications: major morbidity was noted in 1 patient (9%) who developed a large hematoma in the basal ganglia immediately after the procedure. This patient underwent emergent craniectomy and evacuation of hematoma. He had significant weakness of left upper and lower limb and his modified rankin score at the time of discharge was 4. Transient worsening of the 3rd cranial nerve palsy was noted in 2 patients, which regressed gradually with conservative management. Two patients had postprocedural retroperitoneal hematoma that was managed conservatively. One patient developed self-limiting hematuria. The overall incidence of minor complications was 45% (5 patients). No thromboembolic complications were noted.
 
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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
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9857590
MDR Text Key193407784
Report Number2029214-2020-00265
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeIN
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 03/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/19/2020
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 Received03/09/2020
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: 03/19/2020 Patient Sequence Number: 1
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