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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE FLEX INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-475-14
Device Problems Physical Resistance (2578); Detachment of Device or Device Component (2907)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/09/2016
Event Type  Injury  
Manufacturer Narrative
Based on the return of the device, the clinical observation of pushwire detachment was confirmed. As received, the pipeline flex pushwire was detached at the hypotube proximal to the wire weld. The outer diameter of the re-sheathing pad was measured and found to be within specifications. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The pushwire was noted to be bent at 47. 0 cm and 89. 0 cm from the proximal end. Additional analysis of the surfaces of the detached pushwire is underway. A supplemental report will be submitted once the analysis results are available. 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 information during an attempt to deploy a second pipeline flex to treat an unruptured and fusiform left paraophthalmic internal carotid artery aneurysm, a moderate amount of friction was noted in the middle segment during device advancement. According to the physician the pipeline was, "observed to look like a champagne glass. " to troubleshoot, the microcatheter was brought to the inner curve to continue the pipeline flex deployment. At this time, the hypo tube of the pushwire broke proximal to resheathing pad. The segment of the pushwire was retrieved with a gooseneck snare without incident and the procedure was ended. Treatment is planned for the future. There were no patient complications resulting from this event. Vessel tortuosity was moderate. (reference mdr 2029214-2016-00768 for the first pipeline used in the procedure. ).
 
Manufacturer Narrative
The surfaces of the detached pushwire were sent for sem (scanning electron microscope) and eds (energy dispersive spectroscopy) analyses. The analyses confirmed presence of soldering material. The lot history record of the reported lot number was reviewed and no quality issues were identified that would have contributed to this event. Damages noted on the returned device suggest the detachment occurred due to tensile failure. This type of damage has been seen in cases with significant vessel tortuosity. In this case, a moderate amount of friction and tortuosity were noted.
 
Manufacturer Narrative
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.
 
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Brand NamePIPELINE FLEX
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key5925162
MDR Text Key53834608
Report Number2029214-2016-00769
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,Followup
Report Date 09/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/12/2018
Device Model NumberPED-475-14
Device Lot NumberA072944
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/20/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2015
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: 09/02/2016 Patient Sequence Number: 1
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