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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-425-16
Device Problem Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/08/2018
Event Type  malfunction  
Manufacturer Narrative
The pipeline flex device will not be returned for analysis as remains in the patient; therefore, no definitive conclusion can be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic received information that during treatment, the pipeline flex (ped) device migrated proximal after placement.The patient was undergoing flow diversion of a small unruptured saccular aneurysm located in left internal carotid artery, measuring 7mmx5mm, landing zone distal 3mm, proximal 4mm.The vessel was observed as severely tortuous.It was reported that ped was delivered without incident.The proximal end was lazy open; however, it opened once fully deployed.A non-medtronic guidewire was used to smooth expand the ped at the proximal end.The ped looked fully opened and apposed.When the distal end was released, the device was alleged to have migrated proximally.The ped is now partially crossing the neck but not fully covering the neck of the aneurysm.Multiple times were made to cross the ped with the idea to delivery another ped distal to the first.However, the wire was unable to navigate distally.The patient will be retreated.The patient was reported to be asymptomatic and no other complications were reported.The patient was dual antiplatelet treatment.The pru level was 130.
 
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Brand Name
PIPELINE FLEX
Type of Device
INTRACRANIAL 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
9498373700
MDR Report Key8129156
MDR Text Key129465285
Report Number2029214-2018-01018
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00847536016149
UDI-Public00847536016149
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 Physician
Type of Report Initial
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/19/2021
Device Model NumberPED-425-16
Device Lot NumberA678861
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/08/2018
Initial Date FDA Received12/04/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/20/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age39 YR
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