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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-400-18
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/30/2016
Event Type  Injury  
Manufacturer Narrative
Martínez-galdámez, m. , ortega-quintanilla, j. , hermosín, a. , crespo-vallejo, e. , ailagas, j. J. , <(>&<)> pérez, s. (2017). Novel bal loon application for rescue and realignment of a proximal end migrated pipeline flex embolization device into the aneurysmal sac: complication management. J neurointervent surg. Doi:10. 1136/bcr-2016-012263. Rep the pipeline flex device will not be returned for evaluation as it remains implanted in the patient. From the information provided in the article, the event was likely due to mismatch between the inflow and outflow vessel size. Per the article, the pipeline braid was "slightly oversized" in the distal ica. The pipeline flex ifu states, "use of implants with labeled diameter larger than the parent vessel diameter may result in decreased effectiveness and additional safety risk due to incomplete foreshortening resulting in an implant longer than anticipated. " if information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found a report of intraprocedural pipeline flex foreshortening and prolapse into the aneurysm. The patient had presented with dizziness and fatigue. Mr angiography and subsequent ct angiography demonstrated a wide neck, 14 mm left supraclinoid internal carotid artery (ica) aneurysm. Endovascular treatment with a flow diverter was recommended. The article states that during the procedure, a guide catheter was navigated into the left internal carotid artery (ica) through a guiding sheath; a microcatheter was advanced into the left middle cerebral artery (mca) trunk. Due to the short landing zone of the distal ica above the aneurysm neck, the distal end of the pipeline flex 4 x 18 mm was deployed in the mca. The article notes that the device diameter was chosen according to the diameter of the larger proximal parent artery knowing the device would be slightly oversized in the distal ica. Following pipeline flex deployment and microcatheter withdrawal, the proximal aspect of the pipeline flex foreshortened and prolapsed into the aneurysm. The article states that multiple attempts (using a variety of microwires and microcatheter shapes) were made to regain access across the pipeline flex; all attempts were unsuccessful. It was noted that vessel tortuosity (two sharp 90° turns proximal to the aneurysm) made access difficult. Finally, the decision was made to modify the location of the proximal end ped from the inflow to the outflow portion using a balloon technique. The physician advanced a balloon catheter to the aneurysm and managed to use the balloon to realign the pipelineflex with the aneurysm neck. Two additional telescoping pipeline flex devices were placed to cover the aneurysm neck and complete the procedure. The patient had an uneventful postoperative course and was discharged home three days later.
 
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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 Key6939396
MDR Text Key89181657
Report Number2029214-2017-01135
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P100018.S011
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 09/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberPED-400-18
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/10/2017 Patient Sequence Number: 1
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