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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
Model Number FA-71450-35
Device Problems Appropriate Term/Code Not Available (3191); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/28/2015
Event Type  Injury  
Manufacturer Narrative
Kan, p. , mokin, m. , wakhloo, a. , <(>&<)> puri, a. (2015). Techniques in distal access of wide-necked giant intracranial aneurysms during treatment with flow diversion. Surgical neurology international, 6(8), 284. Doi:10. 4103/2152-7806. 157797 the pipeline device will not be returned for evaluation as it remains implanted in the patient; product analysis cannot be performed. The report of pipeline malapposition and foreshortening could not be confirmed; an event cause could not be conclusively determined from the provided information. Mdrs related to this article: 2029214-2017-00872 2029214-2017-00873.
 
Event Description
Medtronic literature review found a report of pipeline incomplete opening as well as foreshortening after deployment. The purpose of this article was to present techniques in distal access of wide-necked giant aneurysms through illustrative cases. The article states that in case 3, the patient presented with headache. Mri and catheter angiography demonstrated a 3 × 2-cm giant left cavernous ica aneurysm. The patient subsequently underwent flow diversion treatment. To obtain distal access, a balloon was inflated within the aneurysm. This reduced the volume of the aneurysm to facilitate access to the distal limb of the parent vessel with the looped-around technique. Two peds (4. 5 × 35 mm followed by a 4. 5 × 20 mm) were deployed across the aneurysm with a 50% overlap. A balloon was then used for angioplasty to address malposition between the first ped and the distal vessel. Upon angioplasty, the two peds became disconnected within the aneurysm and distal access was subsequently lost. On a separate intervention, retrograde access was made to the aneurysm across the anterior communicating artery. Mca access was reestablished, and two additional peds were deployed to connect the disconnected devices. The patient was discharged two days later. The 3-month and 1-year follow-up angiograms showed complete obliteration of the aneurysm.
 
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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 Key6699760
MDR Text Key79577491
Report Number2029214-2017-00872
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 06/15/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFA-71450-35
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 Received06/15/2017
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: 07/10/2017 Patient Sequence Number: 1
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