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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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COVIDIEN (IRVINE) PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-325-16
Device Problem Migration or Expulsion of Device (1395)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/29/2016
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
(b)(4). The pipeline flex braid remains implanted in the patient; the remainder was returned for evaluation. Evaluation is currently in progress. A follow up mdr will be submitted when evaluation is complete.
 
Event Description
Medtronic received report of pipeline flex migration during a procedure. It was reported that the patient was undergoing treatment of an unruptured, amorphous aneurysm at the left vertebra-basilar junction. The aneurysm measured 8mm max diameter and 5mm neck diameter. Landing zone artery size pre-procedure was 3. 00mm distal and 3. 75mm proximal. The vessel was moderately tortuous. The devices were prepared as per ifu. A continuous heparinized saline flush was used during the procedure. The pipeline flex was placed without issue. Upon retrieval of the guidewire, the pipeline flex migrated proximally into the vertebral artery. The physician did not make any attempts to retrieve the pipeline flex; the physician stated the device would eventually endothelialize. The physician suspected that the pipeline flex was undersized for the targeted vessel. Re-measurement on a different projection showed that the vessel was 4mm, as opposed to the original measurement of 3mm. Because of the migration, a second pipeline flex was placed. There was no report of patient injury as a result of this event. Post-procedure angiograph showed that the vertebral and basilar arteries were patent.
 
Manufacturer Narrative
Device evaluation: the pipeline flex delivery system was returned for evaluation without the pipeline flex braid as it was implanted in the patient. The pushwire appeared to be bent. No other anomalies were observed. Based on the analysis findings and event description, the report of pipeline flex migration after deployment could not be confirmed. The pushwire was found to be bent. However, the cause for damage could not be conclusively determined. All products are 100% inspected for damage and irregularities during manufacture. In this event, user error may have contributed to the migration issue. The pipeline flex was incorrectly sized, which may have subsequently caused the pipeline flex braid to migrate. Per pipeline flex instructions for use (ifu), the user should: ¿select an appropriately sized pipeline flex embolization device such that its fully expanded diameter is equivalent to that of the largest target vessel. An incorrectly sized pipeline flex embolization device may result in inadequate device placement, incomplete opening, or migration. ¿.
 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
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
9496801224
MDR Report Key5528120
MDR Text Key108303717
Report Number2029214-2016-00168
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 02/29/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/24/2018
Device Model NumberPED-325-16
Device Lot NumberA079096
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/28/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/25/2015
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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