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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-25
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2015
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex will not be returned for evaluation as it remains implanted in the patient. The device was not returned, therefore the reported event could not be confirmed. An event cause could not be conclusively determined from the reported information.
 
Event Description
Medtronic received report of pipeline flex migration during a procedure. The patient was undergoing flow diversion treatment of a cerebral aneurysm. It is not known whether the vessel was tortuous. The microcatheter was delivered to the distal m1 middle cerebral artery (mca). The pipeline flex was prepared, delivered to the tip of the microcatheter, and the protection sleeve was deployed. It was reported that the physician attempt to resheath the device, but was unable to due to resistance. The pipeline flex system was pulled back until it was distal to the posterior communicating (pcom) artery, which was the implantation site. The physician tried to deploy the device completely, but resheathing was still difficult. The physician was able to resheath the device to the resheathing marker, despite resistance. The pipeline flex was deployed completely. It was reported that when advancing the microcatheter to the distal end of the pipeline flex, foreshortening occurred. In addition, the pipeline flex had partially migrated into the aneurysm. For that reason, an additional pipeline flex device was implanted. Angiographic images were taken to confirm proper deployment. The procedure was completed. The patient is reportedly fine. There have been no reports of patient symptoms as a result of this event.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
9496801224
MDR Report Key6101161
MDR Text Key106786008
Report Number2029214-2016-01010
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/05/2018
Device Model NumberPED-425-25
Device Lot NumberA069399
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 Received11/14/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/06/2015
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: 11/14/2016 Patient Sequence Number: 1
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