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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX 4.75MM X 35MM INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE FLEX 4.75MM X 35MM INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-35
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fistula (1862); Nerve Damage (1979)
Event Date 09/28/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device will not be returned as it remains in the patient. There is no evidence suggesting that the device was defective. We are unable to definitively determine the cause for the reported events.
 
Event Description
Medtronic received information that 5 weeks post pipeline treatment the patient complained of headache and experienced 6th nerve palsy. The 6th nerve palsy is continuing. On follow up angiogram, the patient was found to have a large carotid cavernous fistula (ccf) in the area of the aneurysm. It was reported that the ccf was suspected to be a delayed rupture following the placement of the pipeline across the neck of the aneurysm. The (ccf) was treated with coils and flow was slowed but not stopped. The patient was released with steroid treatment. The physician is planning to place a second pipeline device across the aneurysm neck at a later time. The patient was previously treated for an aneurysm located in the cavernous segment of the right internal carotid artery. The max diameter was 20 mm, and the neck diameter was 14 mm. The patient had moderate vessel tortuosity. It was further reported that there was no defect of the device during the procedure. Flow diversion was evident immediately post procedure. Dapt was administered and pru level was normal limits at time of procedure.
 
Event Description
Medtronic received additional information that the carotid cavernous fistula (ccf) was pre-treated approximately three weeks after initial treatment. It was reported that two pipeline devices were overlapped and axium coils were placed in an effort to increase the flow diversion through the aneurysm/fistula. Despite efforts there was still significant flow through the fistula. The patient was reported to be doing fine.
 
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Brand NamePIPELINE FLEX 4.75MM X 35MM
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key6059352
MDR Text Key106785818
Report Number2029214-2016-00951
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberPED-475-35
Device Catalogue NumberPED-475-30
Device Lot NumberA082656
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 Received11/03/2016
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: 10/26/2016 Patient Sequence Number: 1
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