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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-475-18
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/24/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex delivery system was returned for evaluation with the catheter. As received, the delivery system was stuck inside the catheter and could not be pushed forward or removed. For further examination, the catheter was dissected to remove the pipeline flex delivery system. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The distal and proximal ends of the pipeline flex braid were found fully open with moderate fraying. Kinks and bends were found on the pushwire at a section near the proximal end. Based on the analysis findings and event description, the reports of pipeline flex resistance during retrieval were confirmed. It is possible that the patient¿s moderate vessel tortuosity may have contributed to the reported resistance, subsequently causing the pipeline flex delivery system to become damaged and stuck. However, the cause for resistance could not be determined. Additionally, from the damages seen on the proximal wire (kinking/bending), pipeline flex braid (fraying) and hypotube (stretching) suggest that excessive force was used. In regards to the pipeline flex failure to open at the distal end issue, the report could not be confirmed; the returned pipeline flex braid was found fully open with moderate fraying on both ends. The damage to the ends of the pipeline flex braid is likely the results of the physician re-sheathing the device more than recommended two times. Per our instructions for use (ifu), "the system is designed to allow for 2 full cycles of re-sheathing of the pipeline flex embolization device. Re-sheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. ¿ all products are 100% inspected for damage and irregularities during manufacture.
 
Event Description
Medtronic received report that a pipeline flex did not open during a procedure. The patient was undergoing treatment for an unruptured, saccular cerebral aneurysm. Vessel tortuosity was moderate. The devices were prepared as indicated in the ifu. A continuous heparinized saline flush was used during the procedure. It was reported that the pipeline flex was deployed (>50%) and did not open on the distal end. The pipeline flex was resheathed several times; the distal end still did not open. After resheathing four times, the pipeline flex became locked up in the microcatheter. The system was removed from the patient. The procedure was completed using a new pipeline device. There were no reports of patient injury in connection with 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 Key6422815
MDR Text Key106087228
Report Number2029214-2017-00208
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,Followup
Report Date 02/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/19/2019
Device Model NumberPED-475-18
Device Lot NumberA391718
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/24/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/19/2016
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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