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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
Device Problem Difficult To Position (1467)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/21/2016
Event Type  Injury  
Manufacturer Narrative
The pipeline device was not returned for evaluation as it was implanted in the patient.The device was not returned for analysis, therefore the complaint could not be confirmed, and the event cause could not be conclusively determined.
 
Event Description
Medtronic received report of pipeline foreshortening during a procedure.All devices were prepared as indicated in the ifu.The catheter was flushed during the procedure as indicated in the ifu.It was reported that a pipeline device was deployed without issue, but foreshortened.Due to the foreshortening, a second pipeline device was implanted during the same procedure.There were no reports of patient injury as a result of this event.
 
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Brand Name
PIPELINE EMBOLIZATION DEVICE
Type of Device
INTRACRANIAL 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 Key5807713
MDR Text Key49945221
Report Number2029214-2016-00591
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 06/22/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/22/2016
Initial Date FDA Received07/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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