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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 Problem Therapeutic Response, Decreased (2271)
Event Date 12/14/2015
Event Type  Injury  
Manufacturer Narrative
Duckworth, e. A. Et al. (2015). Separating the wheat from the chaff: region of interest combined with metal artifact reduction for completion angiography following cerebral aneurysm treatment. Journal of neurointerventional surgery, 8(11), 1163-1167. (b)(4). 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 defect of the device during use. The reason for retreatment could not be determined from the information provided in the article.
 
Event Description
Medtronic literature review found a report of retreatment after pipeline implantation. The purpose of the article was to investigate the investigate different methods of two- and three-dimensional angiography to evaluate the correct positioning of implantable devices while limiting radiation dose to the patient. The authors reviewed 9 patients who underwent 10 procedures; 5 of the patients underwent pipeline implantation to treat cerebral aneurysms. Of the 9 patients, 1 patient had a ruptured aneurysm, 8 aneurysms were in the anterior circulation. Average aneurysm size was 11mm. The article states that two patients treated with the pipeline device were retreated with a second device.
 
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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 Key6517259
MDR Text Key73557554
Report Number2029214-2017-00507
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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