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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE FLEX W/SHIELD TECHNOLOGY INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED2-450-20
Device Problems Difficult to Open or Close (2921); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/12/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that the pipeline flex with shield failed to open in the middle section and the distal end appeared not to be opening fully. Resheathed and tried again. The device was brought back slightly into the internal carotid artery (ica) to try and open, but the same thing happened. Initial opening was in a straight section of the anatomy. The device was used per the instructions for use (ifu). No patient injury occurred. The pipeline was reported to have failed to open in the middle section. The device was not deployed in a bend. Less than 50% of the device was deployed when it failed to open. It was resheathed less than or equal to 2 times. The ped and the catheter were removed. Competitor devices were used to treat the patient. The anatomy was moderate in tortuosity.
 
Manufacturer Narrative
The pipeline flex with shield was returned for evaluation stuck within the distal segment of the microcatheter. For further examination, the pipeline flex with shield was then pushed out from the catheter lumen with difficulty. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact with no signs of damage. The outer diameter (o. D) of the re-sheathing pad was measured within specifications. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The distal and proximal ends of the pipeline flex shield braid were fully opened and moderately frayed. The pushwire appeared to be bent near the proximal end. 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 and the event descriptions, the failure to open issue could not be confirmed, as the returned pipeline flex shield braid was found fully opened and moderately frayed at both ends. Possible contributing factors include patient's vessel tortuosity and damaged braid. The damage to the braid on the ends of the pipeline flex with shield is likely the results of the customer re-sheathing the device more than recommended two times. 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 W/SHIELD TECHNOLOGY
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 Key7758012
MDR Text Key116632957
Report Number2029214-2018-00700
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
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
Report Date 10/03/2018
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 Date02/26/2021
Device Model NumberPED2-450-20
Device Lot NumberA604454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
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 Manufactured02/27/2018
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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