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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage, Intraventricular (1892); Hemorrhage, Subarachnoid (1893); Tachycardia (2095); Vasoconstriction (2126); Cognitive Changes (2551)
Event Date 11/12/2019
Event Type  Death  
Manufacturer Narrative
The pipeline devices have not been returned for evaluation; product analysis cannot be performed. The devices have not been returned; the reported events could not be confirmed. The causes of the events could not be conclusively determined from the reported information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Kilburg c j, park m s, kalani y, et al. (november 12, 2019) poor results of flow diversion as salvage treatment for intracranial aneurysm rerupture after surgical clip reconstruction. Cureus 11(11): e6137. Doi 10. 7759/cureus. 6137 medtronic literature review found reports of patient deaths after pipeline implantation. Case 1: a patient ((b)(6) years, female) underwent clip reconstruction of a right anterior choroidal artery aneurysm measuring approximately 2×8 mm. Fourteen days post-procedure, the patient had an acute worsening of her headache followed by a rapid decline in her neurologic examination until she exhibited only extensor posturing to noxious stimuli (hunt hess 5). An emergent dsa confirmed a recurrence of the aneurysm, which was projected superiorly from the clip site and measured approximately 8 mm in its maximal dimensions. The patient underwent pipeline placement to treat the recurrence. Immediate follow-up angiograms after deployment demonstrated contrast stasis within the recurrence. At the time of the angiogram, the patient was also noted to have severe anterior circulation vasospasm bilaterally that was treated with an intra-arterial infusion of verapamil. After the procedure, she remained intubated with severely depressed neurologic examination findings. Repeat cerebral angiogram the next day showed continued severe anterior circulation vasospasm that was treated with intra-arterial verapamil and angioplasty of the left middle cerebral artery. Later that night, she had an acute elevation of her intracranial pressure to >90 mmhg and further decline of her neurologic examination. Aggressive medical management was initiated including boluses of sedation, hypertonic saline, and mannitol. Her intracranial pressure improved, but remained elevated at approximately 30 mm hg. A repeat ct scan of the head demonstrated extensive new intraventricular hemorrhage concerning for repeat aneurysm rupture. Shortly after the scan, the patient developed ventricular tachycardia, experienced cardiac arrest, and died. Case 2: a patient (female, (b)(6) years) presented with diffuse, thick subarachnoid hemorrhage, a small amount of intraventricular hemorrhage, and an intraparenchymal hemorrhage within the inferior left frontal lobe (fisher grade 4). The patient was taken to the operating room that day for a left frontotemporal craniotomy for clip reconstruction of the aneurysm with a single fenestrated clip. Postoperatively, her neurologic examination findings remained depressed but consistent with her examination at presentation. On hospital day 22, the patient became acutely somnolent. A ct scan of the head demonstrated new subarachnoid hemorrhage around the clip site and a new, thin subdural hematoma along the left convexity concerning for aneurysm rerupture. An emergent dsa showed a new dorsal variant aneurysm just distal to the previous clip site. The new aneurysm was multilobulated and measured approximately 7 mm in its maximal dimensions. There was also evidence of active pulsations within the aneurysm during angiography. The collective decision of the patient¿s family, and the treating neurosurgeon was to proceed with treatment by flow diversion. The patient was given 10 mg of intravenous abciximab, and a 4. 5×25 mm pipeline flex device was placed across the aneurysm. The patient was then given a second dose of 10 mg of abciximab. To provide as much protection as possible, the decision was made to cover the aneurysm with a second flow diverter. Another 4. 5×20 mm pipeline flex device was then placed within the first device in a duplicative fashion. An immediate follow-up angiogram demonstrated good contrast stasis within the aneurysm. Immediately after the procedure, the patient was taken for a repeat ct scan, which demonstrated new, diffuse subarachnoid hemorrhage and intraventricular hemorrhage, which was expected due to her prior decline in her neurological status. On examination, her pupils were nonreactive bilaterally and she was not responding to noxious stimuli. She also required a vasopressor infusion to maintain her hemodynamic function. The patient¿s family decided to withdraw care, and the patient died.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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 Key9925538
MDR Text Key187169794
Report Number2029214-2020-00326
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 04/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/03/2020
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 Received03/10/2020
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: 04/03/2020 Patient Sequence Number: 1
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