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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 Infarction, Cerebral (1771); Intracranial Hemorrhage (1891); Therapeutic Response, Decreased (2271); Thromboembolism (2654); Hydrocephalus (3272)
Event Date 11/26/2015
Event Type  Injury  
Manufacturer Narrative
Daou, b. Et al. (2015). Pipeline embolization device in the treatment of recurrent previously stented cerebral aneurysms. American journal of neuroradiology, 37(5), 849-855. Doi:10. 3174/ajnr. A4613 the pipeline devices will not be returned for evaluation as they remain implanted in the patients. Based on the information provided in the article, there did not appear to have been any defects of the devices during use. The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information. Mdrs related to this article: 2029214-2017-00521 2029214-2017-00522 2029214-2017-00523.
 
Event Description
Medtronic literature review found reports of patient complications during or after pipeline implantation. The purpose of this article was to evaluate the efficacy and safety of the pipeline embolization device (ped) in the treatment of recurrent, previously-stented aneurysms. The authors identified 21 patients with previously-stented recurrent aneurysms who underwent retreatment with ped. These patients were compared with 63 patients who had treatment with the ped without prior stent placement. Of the previously-stented group, two previously-stented aneurysms managed with the ped required another retreatment, with placement of another ped. In patients with no prior stents, four patients required retreatment post-ped placement. Of the previously-stented group, four patients had an unfavorable outcome (19%), which included one patient with an mrs score of 3, one patient with an mrs of 4, and one patient with an mrs of 5. In patients with no prior stent placement, 6. 8% of patients had a ¿poor clinical outcome. ¿ the article states that three patients in the previously-stented group experienced complications within 30 days of treatment: - one patient with a giant vertebrobasilar artery aneurysm had a posterior cerebral artery territory infarct and later developed hydrocephalus requiring ventriculoperitoneal shunting and then developed multiple shunt infections (mrs 5). - one patient had retinal emboli causing visual changes (mrs 1) after ped treatment of a carotid ophthalmic aneurysm. The article states that six patients in the ped-only group experienced complications within 30 days of treatment. The complications included two intracerebral hemorrhages, one mca infarcts, and one basal ganglia stroke.
 
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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 Key6517579
MDR Text Key73557656
Report Number2029214-2017-00522
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 03/28/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2017
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 Received03/28/2017
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: 04/24/2017 Patient Sequence Number: 1
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