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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-250-10
Device Problem Difficult To Position (1467)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/27/2016
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device was not retuned for evaluation as it remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.
 
Event Description
Medtronic received information that the pipeline was bumped causing the distal end of the pipeline to fall into the proximal aneurysm as the tip coil proximal to the pipeline was being re-captured. The pipeline was implanted in the intended location with full wall apposition, but the distal end was left inside the dome of the aneurysm despite several attempts to re-gain access. Retrieval of the pipeline was not optimal; therefore, the pipeline was left in the patient. The physician plans to bring the patient back in two months to check the aneurysm. There were no patient symptoms reported.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92703
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA 92703
Manufacturer Contact
tricha miles
9775 toledo way
irvine 92618
9496801224
MDR Report Key6124699
MDR Text Key106843637
Report Number2029214-2016-01050
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 10/27/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberPED-250-10
Device Lot NumberA303454
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 Received10/27/2016
Was Device Evaluated by Manufacturer? No
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: 11/23/2016 Patient Sequence Number: 1
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