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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-500-25
Device Problems Physical Resistance (2578); Activation Failure (3270)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2016
Event Type  malfunction  
Manufacturer Narrative
Corrected information: sex. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
The device has not been returned for evaluation; therefore, the reported event could not be confirmed. A supplemental report will be submitted once the device is returned.
 
Event Description
Medtronic received information that during treatment of an aneurysm located in the cavernous segment of the ica, the pipeline did not open distally as the patient had severe vessel tortuosity. There was also a report of movement during placement, moderate difficult placement/positioning. It was reported that the patient had a proximal loop in ica and a torturous posterior and anterior genuine of ica. During advancement of the pipeline through the marksman at the cavernous segment, the tip of the system at the distal marker appeared to be kinked at a 45 degree angle. This kink was present as the device was advanced up to the m1 segment. During initial delivery the delivery wire at the distal marker appeared to be kinked and the pipeline device was opening in a trumpet shape. There was resistance encountered during advancement of the pipeline within the distal segment of the marksman. After resheathing multiple times, the device exhibited the same trumpet shape and the physician decided to abort the procedure. The device was removed by retracting the marksman and pipeline into the guide catheter and removed from the patient. No patient injury was reported. Post angiography result was normal. The aneurysm was unruptured and saccular. The max diameter was 13 mm and the neck diameter was 10 mm. The distal landing zone was 4. 9 mm and the proximal was 4. 2 mm. More than 50 percent of the device was deployed, and the device was resheathed less than or equal to 2 times.
 
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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 92618
9496801224
MDR Report Key6139457
MDR Text Key151431336
Report Number2029214-2016-01081
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 11/04/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2019
Device Model NumberPED-500-25
Device Lot NumberA294091
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/04/2016
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/14/2016
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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