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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-18
Device Problem Activation Failure (3270)
Patient Problem Fistula (1862)
Event Date 10/19/2016
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 for evaluation as it was implanted in the patient. Without return of the device, no definitive conclusions can be drawn regarding the clinical observation. Mdrs related to this report: 2029214-2016-01014. A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during treatment of an aneurysm located in the left internal carotid artery (ica), two pipelines did not open. In addition, the carotid became occluded forming a cavernous carotid fistula. After further imaging and checking patency of the circle of willis the physician sacrificed the carotid artery. It was reported that the first ped-425-18 did not open proximally and the second device did not open distally as they were positioned in a bend. Proximal segment landed in a curve, slow flow was noted. A second ped-450-16 device was implanted and overlapped to extend the device into a straight segment, both pipelines remain in the patient. After deployment of the second device the carotid became occluded forming a ccf. The ccf was treated with coils and post angio showed carotid was coiled. The patient is currently doing fine. The aneurysm was unruptured and saccular, the max diameter is not known. The neck diameter was 4. 5 (mm) and the distal landing zone was 4. 0 mm and the proximal was 4. 25 mm. The patient had moderate vessel tortuosity.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key6101216
MDR Text Key106524391
Report Number2029214-2016-01013
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
Report Date 10/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberPED-425-18
Device Lot NumberA303456
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 Received10/19/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/30/2016
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: 11/14/2016 Patient Sequence Number: 1
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