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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-500-12
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/03/2017
Event Type  malfunction  
Manufacturer Narrative
Device evaluation: the pipeline flex delivery system was returned for evaluation and based on the analysis findings and the event descriptions, the clinical observations were confirmed as the received pipeline braid was found not opened due to damaged braid. The distal and proximal dps restraints were found to be intact. The dps sleeves were found intact with no signs of damage. Dried blood was observed on the dps sleeves. The distal hypotube appeared to be stretched with the ptfe shrink tubing still intact. The distal end of the pipeline braid were found not opened with severely frayed. The proximal end of the pipeline braid was found fully opened with moderately frayed. The pushwire was found to be bent at 35. 5 cm from 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. The returned catheter was also found to be accordioned. From the damages seen on the catheter body (accordioning), proximal wire ( bending), hypotube (stretching) and pipeline braid (fraying); it appears there was high force used. It is likely these damages occurred when the customer attempted to advance the pipeline flex delivery system through the catheter against the reported resistance. Per our instructions for use (ifu): ¿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 intraluminal 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. Begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously. After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device. Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device. The pipeline flex embolization device is fully resheathed when the distal marker is retracted completely inside the micro catheter. The system is designed to allow for 2 full cycles of resheathing of the pipeline flex embolization device. Resheathing the pipeline flex embolization device more than 2 full cycles may cause damage to the distal or proximal ends of the braid. ¿ if information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device has been received, but the analysis has yet not been completed. A supplemental report will be submitted. Mdr linked with: 2029214-2017-01309. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received report that two flow diverter devices did not open at distal section, and when they were removed they both remained pinched at the proximal end. No patient injury occurred.
 
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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
tricha miles
9775 toledo way
irvine, CA 92618
9492753836
MDR Report Key7061495
MDR Text Key249017642
Report Number2029214-2017-01308
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 12/11/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/08/2020
Device Model NumberPED-500-12
Device Lot NumberA473179
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/06/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/09/2017
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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