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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-475-14
Device Problems Deformation Due to Compressive Stress (2889); Difficult to Open or Close (2921); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex embolization device will not be returned for evaluation as it was discarded; therefore, product analysis cannot be performed. The device was not returned; therefore, the reported event could not be confirmed. The cause of the event cannot be conclusively determined from the provided information. Related mdrs for this event: 2029214-2018-00653 and 2029214-2018-00654. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that the first pipeline flex embolization device would not open on the distal end during the treatment of a blister aneurysm located in the cavernous segment of the internal carotid artery(ica). It was reported that pipeline was removed from the patient. It was stuck in the microcatheter, but the distal segment still would not open. The physician chose another pipeline flex embolization device, but this pipeline became kink and would not open. This pipeline was also stuck in the microcatheter and removed from the patient. The patient was treated with another pipeline and was reported to be fine post procedure and went home the same day. No patient injury was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA
Manufacturer (Section G)
COVIDIEN (IRVINE)
9775 toledo way
irvine CA
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key7719888
MDR Text Key115355461
Report Number2029214-2018-00653
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 10/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/17/2019
Device Model NumberPED-475-14
Device Lot NumberA345274
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/17/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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