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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); Intracranial Hemorrhage (1891); Thrombosis (2100); Visual Impairment (2138)
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. Linked with mdr: 2029214-2020-00618. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Andrew griffin, emily lerner, adam zuchowski, ali zomorodi, l. Fernando gonzalez, erik f. Hauck ¿flow diversion of fusiform intracranial aneurysms¿ twenty-nine patients with 30 fusiform aneurysms. The mean age was 50 years (10¿72 years) and 48% were female. Ped placement was technically successful in 100% of cases. Retreatment was necessary in four cases due to persistent aneurysm opacification on follow-up angiography. Three aneurysms were treated with placement of additional flow diverters and one patient required surgical bypass. The overall complication rate was 26. 7% with a neurological morbidity rate of 6. 7% (2) and neurological mortality rate of 3. 4% (1). The most common complications included groin hematoma (n
=
2, 6. 7%) and healthcare-associated pneumonia (n
=
2, 6. 7%). One patient suffered groin pseudoaneurysm and another was reported to have experienced blindness. One patient suffered a brainstem stroke due to acute thrombosis of a 19. 9-mm basilar trunk aneurysm, which required tracheostomy and percutaneous gastrostomy tube placement. This patient died 1. 5 years later from sepsis due to pneumonia. Another patient suffered an intraparenchymal hemorrhage after placement of a ventriculoperitoneal shunt. This occurred 7 days after placement of the pipeline embolization device. Dual antiplatelet therapy had been held and the patient was transfused two units of platelets prior to the procedure but suffered a small tract hemorrhage. She ultimately made a full neurological recovery. All patients with unruptured aneurysms were discharged with a good mrs score (0¿2). Of the seven patients with ruptured fusiform aneurysms, three were discharged with good mrs and four had a good mrs at 12-month follow-up.
 
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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 Key10207163
MDR Text Key201179241
Report Number2029214-2020-00619
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
Report Date 06/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2020
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 Received06/22/2020
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: 06/29/2020 Patient Sequence Number: 1
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