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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); Intracranial Hemorrhage (1891); Hemorrhage, Subarachnoid (1893); Ischemia (1942); Occlusion (1984); Transient Ischemic Attack (2109); Loss of Vision (2139); Stenosis (2263); Therapeutic Response, Decreased (2271)
Event Date 10/06/2017
Event Type  Injury  
Manufacturer Narrative
Almandoz, j. E. , kayan, y. , tenreiro, a. , wallace, a. N. , scholz, j. M. , fease, j. L. ,. Tenreiro-picón, o. (2017). Clinical and angiographic outcomes in patients with intracranial aneurysms treated with the pipeline embolization device: intra-procedural technical difficulties, major morbidity, and neurological mortality decrease significantly with increased operator experience in device deployment and patient management. Neuroradiology, 59(12), 1291-1299. Doi. Org/10. 1007/s00234-017-1930-z. The pipeline devices will not be returned for evaluation as they remain implanted in the patients. Based on the provided information, there does not appear to have been any defects of the devices during use. The events occurred in the patients post-procedure and its cause could not be conclusively determined from the reported information. Mdrs related to this article: 2029214-2018-00220, 2029214-2018-00222, 2029214-2018-00223, and 2029214-2018-00224. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found reports of patient complications after pipeline implantation. The purpose of this article was to determine whether outcomes after pipeline (ped) treatment improve with operator experience. The authors retrospectively reviewed 140 patients who underwent 150 ped procedures to treat 167 intracranial aneurysms. Of the patients, 109 were women and 31 were men; the mean age was 55. 4 years. The article noted the following peri-operative complications: - five major ipsilateral intracerebral hemorrhages (ich). It was noted that four of the five patients had marked p2y12 receptor over-inhibition (pru
=
10) at the time of ich - four major ipsilateral ischemic strokes - five minor ipsilateral ischemic strokes with transient deficits - one ipsilateral peripheral subarachnoid hemorrhage the article noted the following delayed complications: - one central retinal artery occlusion with monocular blindness after aspirin discontinuation 2. 5 years after the ped procedure - two asymptomatic ped occlusions - one amaurosis fugax - one ipsilateral ischemic stroke with transient deficits the article also notes that four patients underwent retreatment in which an additional ped was placed.
 
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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 Key7366031
MDR Text Key103322706
Report Number2029214-2018-00221
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 health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 03/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/23/2018
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 Received02/27/2018
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: 03/23/2018 Patient Sequence Number: 1
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