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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-300-20
Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Therapeutic Response, Decreased (2271)
Event Date 04/25/2016
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 cause of residual aneurysm could not be conclusively determined from the reported information.
 
Event Description
Medtronic received report that a patient underwent retreatment one year after pipeline flex implantation. The patient reportedly was retreated due to residual aneurysm. There were no reports of patient symptoms in connection with this event. The patient had received the pipeline flex to treat a fusiform aneurysm in the right v4 vertebral artery. The aneurysm dome was 6. 1mm and neck diameter was 5. 4mm. There were no device issues noted during the implantation procedure.
 
Manufacturer Narrative
Additional information the customer¿s report of pipeline flex migration after deployment could not be confirmed and the event cause could not be determined. It is possible that the braid under-sizing may have contributed to the reported issue. Per our instructions for use (ifu): ¿select an appropriately sized ped such that its fully expanded diameter is equivalent to that of the largest target vessel diameter. An incorrectly sized ped may result in inadequate device placement, incomplete opening, or distal migration. ¿ a good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received additional event information: one year post-implantation, the patient was found to have residual aneurysm measuring 5mm wide, 6. 2mm length, and 5. 75mm base. The site noted ¿device migration¿ as the reason for retreatment. Per the procedure notes, the pipeline flex was in position and well-apposed to the vessel wall. The patient elected to undergo endovascular treatment in which two additional pipeline devices were implanted. After placement of the two pipeline devices, there was continued flow within the right pica and significantly stagnated flow within the pica aneurysm.
 
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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 Key6012274
MDR Text Key106748758
Report Number2029214-2016-00880
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 health professional,study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 09/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/19/2018
Device Model NumberPED-300-20
Device Lot NumberA061515
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 Received12/01/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/20/2015
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: 10/07/2016 Patient Sequence Number: 1
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