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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-375-35
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2018
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex embolization device will not be returned as it remains in the patient; 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. Per pipeline¿ flex embolization device instruction for use (ifu): place the micro catheter tip at least 20 mm past the distal edge of the aneurysm. Gently retract the micro catheter to reduce slack in the micro catheter prior to inserting pipeline¿ flex embolization device. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received a reported of pipeline flex embolization device (pfed) that, this pipeline collapse into the aneurysm during the procedure. The patient underwent embolization treatment of a giant unruptured fusiform aneurysm located in cavernous sinus segment. Aneurysm dimensions 25mmx18mm, landing zone distal 3. 62mm proximal 4. 6mm. It was reported that reported pfed was first in the procedure and implanted successfully. When second flow diverter opened at the distal end of the first reported pfed, this second flow diverter could not be fully recovered and that causing the first pfed to collapse into the aneurysm. The second flow diverter was removed from the patient with microcatheter. Another new flow diverter was used to complete the construct. Post procedure angiographic result, the blood vessel revascularization was completed, and the blood flow of the aneurysm was obvious. The vessel was moderately tortuous. No patient injury was reported.
 
Manufacturer Narrative
Only pipeline flex pushwire was returned for evaluation as pipeline flex braid was implanted in the patient. There was not any bend or damages were found with the returned pushwire. Based on the returned pushwire evaluation cause of the reported event could not be reliably determined. The possible contributing factor includes using an under-sized braid. Per our instructions for use (ifu): ¿do not use the pipeline flex embolization device in vessel diameters that are larger than the labeled diameter. Select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel. An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration. ¿ if information is provided in the future, a supplemental report will be issued.
 
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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
9498373700
MDR Report Key7570647
MDR Text Key110174248
Report Number2029214-2018-00484
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCH
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
Report Date 08/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/08/2020
Device Model NumberPED-375-35
Device Lot NumberA567828
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/09/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2017
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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