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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-425-20
Device Problems Difficult to Open or Close (2921); Mechanical Jam (2983); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/28/2018
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned but has yet not been received. Since the device was not returned, we are unable to perform further root cause analysis. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report of pipeline flex did not open in the middle section. The patient underwent embolization treatment for a small unruptured amorphous located in para ophthalmic measuring 5mmx3mm, landing zone distal 3. 5mm, proximal 4mm. The vessel was moderately tortuous. It was reported that the catheter was raised to the distal portion of the aneurysm and when trying to retract the pipeline it was locked inside microcatheter. The pipeline resheathed and was removed with the microcatheter from the patient.
 
Manufacturer Narrative
Additional manufacturer narrative - additional information based on the corrected event description, this event is no longer mdr reportable. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received correct event information: it was reported that the pipeline flex became locked up in the microcatheter during a procedure.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The pipeline flex pushwire was returned for evaluation without the braid. Any contributing factors from the pipeline flex braid could not be assessed. The distal hypotube and ptfe shrink tubing were found to be intact with no signs of elongation. No bends were observed on the pushwire. No defects were found with the tip coil, distal marker, re-sheathing marker or with the proximal bumper. No other anomalies were observed. Based on the analysis findings, the event descriptions, the customer complaint was not confirmed. The event cause could not be determined as the pipeline flex pushwire was returned without the braid. No evidence was found to indicate that the device failed to meet specifications; therefore, manufacturing has been ruled out as a po tential cause. All products are 100% inspected for damage and irregularities during manufacture. If information is provided in the future, a supplemental report will be issued.
 
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Brand NamePIPELINE FLEX
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 Key7724621
MDR Text Key115401267
Report Number2029214-2018-00666
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAR
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 10/08/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/09/2019
Device Model NumberPED-425-20
Device Lot NumberA274517
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/09/2016
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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