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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-475-30
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/13/2018
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex device was not returned for analysis; therefore, no definitive conclusion can be drawn regarding the clinical observation. However, the device is pending return. Upon receipt of the device and/or additional information a supplemental report will be filed. Related mdrs for this event: 2029214-2018-01027, 2029214-2018-01028. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that this reported pipeline flex pushwire broke during the procedure. The patient was undergoing flow diversion of an unruptured a medium size unruptured saccular aneurysm located in cavernous segment in right internal carotid artery. The vessel was observed moderately tortuous. It was reported that the physician tried to deliver this pipeline through non-medtronic catheter but unable to delivered through the catheter and the pushwire broke on pipeline. The pipeline was removed from the patient and no harm or device was left in patient. The physician then exchanged for a medtronic catheter and successfully deployed third pipeline and completed the procedure. There were no reports of patient injury in association with this event.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL 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
9498373700
MDR Report Key8142046
MDR Text Key129782745
Report Number2029214-2018-01028
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
Report Date 12/07/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2019
Device Model NumberPED-475-30
Device Lot NumberA367476
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 Received11/13/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/28/2016
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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