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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Intimal Dissection (1333); Infarction, Cerebral (1771); Hemorrhage/Bleeding (1888); Therapeutic Response, Decreased (2271)
Event Date 04/10/2017
Event Type  Injury  
Manufacturer Narrative
Chalouhi, n. (2017). Matched comparison of flow diversion and coiling in small, noncomplex intracranial aneurysms. Neurosurgery. Doi :10. 1093/neuros/nyw070 the pipeline devices will not be returned for evaluation as it remains implanted in the patients. The device were not returned; the events reported in the article could not be confirmed. The causes of the events could not be conclusively determined from the provided information.
 
Event Description
Medtronic literature review found reports of patient complications after pipeline implantation. The purpose of this article was to compare coiling and flow diversion (pipeline) in the treatment of small, uncomplicated intracranial aneurysms (typically amenable to coiling). Forty patients underwent treatment with the pipeline embolization device (ped); the average age was 54. 8 years; 10% of the patients were male. All aneurysms were saccular, unruptured, narrow-necked, had a favorable fundus-to-neck ratio (>1. 5), and were located in the anterior circulation. The article states that there were two complications in the ped group: - one patient developed right-sided weakness post-operatively from left-sided hemispheric infarcts with hemorrhagic conversion. At the one-year follow-up, the patient had made a full neurological recovery. - one patient developed transient neurological symptoms. Head computed tomography (ct) did not show any infarcts or hemorrhages, but ct angiography (cta) of the head and neck showed a short segment of dissection of the common carotid artery. The patient was discharged neurologically intact on coumadin. In addition, the article states that two of the 40 ped patients required retreatment.
 
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Brand NamePIPELINE EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9496801224
MDR Report Key6566550
MDR Text Key75145904
Report Number2029214-2017-00644
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 04/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/15/2017
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 Received04/17/2017
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: 05/15/2017 Patient Sequence Number: 1
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