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U.S. Department of Health and Human Services

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

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MICRO THERAPEUTICS, INC. DBA EV3 PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-475-14
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Pain (1994); Dyskinesia (2363); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 06/17/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Kaka, h. , larrazabal, r. , & van adel, b. (2021). Use of the pipeline shield in the posterior circulation with single antiplatelet therapy: a case of delayed in-stent thrombosis.  the canadian journal of neurological sciences. Le journal canadien des sciences neurologiques, 1¿8. Https://doi. Org/10. 1017/cjn. 2021. 135 medtronic review of the literature document found a case report of a patient who underwent a procedure for pipeline shield implantation to treat a ruptured dissecting posterior circulation aneurysm. The patient developed a severe thunderclap headache at home and was transported to the hospital after being found collapsed, confused and incontinent. In the emergency department, that patient was fully alert and responsive but reported horizontal diplopia and severe headache with pain rated 10/10. Examination revealed a left sixth nerve palsy. World federation 55 of neurosurgical societies grading was 1. Cranial computer tomography (ct) showed diffused subarachnoid hemorrhage (sah) without ventricular extension. Ct angiography identified a dissecting aneurysm involving the v4 segment of the left vertebral artery (va) which was additionally confirmed with cerebral angiography. The patient received a loading dose of aspirin 325mg and was treated on post-sah day 2 under general anesthesia. A triaxial system was utilized, and with full heparinization, a phenom 27 microcatheter was advanced over an 0. 014 inch microguidewire into the left vertebral artery, beyond the abnormal vessel segment, and into the proximal basilar artery. After implantation of one pipeline shield stent, residual aneurysm filling was observed so an additional pipeline shield was also implanted successfully. Repeat angiographic runs confirmed patency of the left va, basilar artery, and associated branches. Reflux opacification was seen in the right vertebral artery. Decreased filling was observed after implantation of the second pipeline shield. There was no report of any device malfunction. The patient recovered well remaining on single antiplatelet therapy of aspirin 81mg daily. The patient discharged home on day 14 post-sah with noted persistent diplopia due to partial left sixth nerve palsy that had been observed prior to treatment. The next day (day 13 post-procedure), the patient returned to the hospital with sudden onset headache and left side neck pain with mild discoordination. Neurological examination demonstrated dysmetria of the left upper and lower extremities with persistent left sixth nerve palsy. Ct and magnetic resonance (mr) angiography showed acute thrombosis of the left extracranial v3 segment extending to the intracranial left v4 segment just proximal to the vertebrobasilar junction, with complete thrombosis of the ped-shield stents. The contralateral right va and basilar artery remained patent. There was no opacification of the left posterior inferior cerebellar artery remained patent. There was no opacification of the left posterior inferior cerebellar artery (pica). Mri demonstrated small ischemic infarcts within the left cerebellar hemisphere and in the bilateral occipital lobes, likely secondary to the in-stent thrombosis and left pica and va occlusion. The patient was monitored for 24 hours then discharged home in stable condition. 30 days later, the patient was seen at the clinic and had improvement of the sixth nerve palsy symptoms. The patient resumed function at baseline. The conclusion of the single case study was that although pipeline shield is designed to be less thrombogenic, dual antiplatelet treatment (dapt) may still be the safer anticoagulant treatment approach, particularly in the early post-operative period, particularly when multiple overlapping stents are implanted.
 
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Brand NamePIPELINE FLEX W/SHIELD TECHNOLOGY
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
david gustafson
9775 toledo way
irvine, CA 92618
7635149628
MDR Report Key12135837
MDR Text Key261692366
Report Number2029214-2021-00838
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
P100018.S026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED2-475-14
Device Catalogue NumberPED2-475-14
Device Lot NumberUNKNOWN
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 Received06/23/2021
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: 07/08/2021 Patient Sequence Number: 1
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