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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX WITH SHIELD INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX WITH SHIELD INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-450-16
Device Problems Retraction Problem (1536); Difficult to Open or Close (2921); Positioning Problem (3009); Activation Failure (3270)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 07/11/2018
Event Type  malfunction  
Manufacturer Narrative
The device has been received. However, the device analysis has yet not began. A supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that during the procedure, the pipeline was delivered to the intended location and deployed distally and failed to open and had to be repositioned. The pipeline then could not be sheathed, as the pipeline could not be pulled back into the microcatheter. It was decided to pull out pipeline and microcatheter together. There was resistance in the distal section of the catheter. There was no patient injury. The catheter was flushed continuously with heparinized saline. The devices were each prepared and used per the instructions for use (ifu). The anatomy was tortuous.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Based on the analysis findings, the event descriptions, the report of failure to open at the distal end was not confirmed as the distal end and proximal ends of the pipeline flex with shield braid appeared to be fully opened and moderately frayed. It¿s possible that the patient¿s vessel tortuosity may have contributed to the failure to open issue. The damage to the braid on the ends of the pipeline flex with shield is likely the results of the re-sheathing the device more than recommended two times. Regarding failure to resheath and resistance issues, the complaint was confirmed as the returned pipeline flex with shield appeared to be stuck at the distal segment of the catheter. The returned pipeline flex with shield and the catheter were found to be damaged. It was reported that the patient¿s vessel was tortuous. In addition, the devices were prepared per the instructions for use (ifu) and a continuous flush with heparinized saline was maintained during procedure. It¿s possible that the patient¿s vessel tortuosity may have contributed to the resistance during delivery. From the damages seen on the catheter body (stretching/accordioning), pipeline flex shield braid (fraying), proximal wire (bending) and hypotube (stretching); it appears there was high force used (pushing and pulling). It is likely these damages occurred when attempted to advance/retrieve the pipeline flex with shield through the microcatheter against the resistance. Per our instructions for use (ifu), the user should: ¿begin to deliver the device using a combination of unsheathing the pipeline flex with shield embolization device and pushing delivery wire simultaneously. After the distal end of the pipeline flex with shield has successfully expanded, deploy the remainder of the device. The system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex with shield embolization device. Re-sheathing the pipeline flex with shield embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. Discontinue delivery of the device if high force or excessive friction is encountered during delivery. Identify the cause of the resistance and remove device and microcatheter simultaneously. Advancement of the ped against resistance may result in device damage or patient injury. Never advance or withdraw an intralumenal device against resistance until the cause of resistance is determined by fluoroscopy. If the cause cannot be determined, withdraw the catheter. Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel. Do not use in pat ients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis. ¿ all products are 100% inspected for damage and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX WITH SHIELD
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
gabriela mclellan
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7758700
MDR Text Key116860656
Report Number2029214-2018-00701
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeGM
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,Followup
Report Date 10/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/07/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/23/2018
Device Model NumberPED2-450-16
Device Lot NumberA178217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2018
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? Yes
Date Device Manufactured10/24/2015
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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