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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-425-35
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Foreign Body In Patient (2687)
Event Date 11/01/2016
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. 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 superior hypophyseal, the pipeline moved due to exertion of forces, as the patient had severe vessel tortuosity. It was reported that the pipeline was implanted however moved to an unintended location and a1 branch was covered. The pipeline was left in after unsuccessful attempts to regain access and telescope the pipeline were made. Two days later additional attempts were made to regain access, which included going up the contralateral side to try to gain access through the anterior communicating artery (aca) and push or access behind the pipeline with the use of multiple wires and a snare device. However, all attempts failed, the pipeline moved during these attempts proximally, but still stayed apposed and in position distally into in m 1 and proximal segment is floating in aneurysm. A decision was then made to sack the carotid below the aneurysm due to sufficient collateral and posterior communicating artery flow. For the sacking left carotid, the physician proceeded to coil off the aneurysm and also the internal carotid artery (ica) proximally to the aneurysm to shut off blood flow entirely. No further treatment is planned at this time.
 
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Brand NamePIPELINE FLEX
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 Key6130114
MDR Text Key106787282
Report Number2029214-2016-01062
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 11/01/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/28/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2019
Device Model NumberPED-425-35
Device Lot NumberA280230
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 Received11/01/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/19/2016
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: 11/28/2016 Patient Sequence Number: 1
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