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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 Problems Difficult To Position (1467); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/26/2015
Event Type  malfunction  
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. The pipeline devices will not be returned for evaluation as they remain implanted in the patients. The devices were not returned, therefore, the events reported in the article could not be confirmed. The causes of the events 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 technical difficulties during 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. The article states that in the previously-stented group, the following technical difficulties occurred: in one patient, the distal two-thirds of the ped was deployed with good wall apposition; however, because of prior stent placement, the proximal third did not open and good wall apposition was not achieved. In two patients, there were difficulties in placing the ped across the neck of the aneurysm and achieving appropriate overlap with the previous stent and covering the proximal tines of the stent. The article states that in the ped-only patients, technical difficulties occurred for three patients: in two patients, there were difficulties in opening the proximal part of the ped during deployment. The patients had severe tortuosity of the inflow of the aneurysm. A balloon was used to expand the device. The article did not note any patient injuries in connection with these events.
 
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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 Key6517575
MDR Text Key73566507
Report Number2029214-2017-00521
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
0 Patients were Involved in the Event:
Date FDA Received04/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
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

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