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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC COVIDIEN PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER

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MEDTRONIC COVIDIEN PIPELINE FLEX EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Model Number PED-450-14
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/04/2015
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device was not returned as it remains implanted in the patient. No device issue was reported in this event. It was reported that the patient received dual anti-platelet treatment post procedure and the pru level was found to be 54 at the time of hospital admission. Literature review showed that pru level lower than 60 carry higher odds of hemorrhagic complications (daou, 2015), intracerebral bleeding is a known inherent risk of pipeline procedure and is documented in the pipeline flex instruction for use. The cause of the iph cannot be reliably determined; however, per the reported information, review of ifu, and review of literature to investigate the event, the most likely cause for the event is patient condition ¿ clopidogrel hyper-response. Same event as reported in mdr mfr: 2029214-2015-05175.

 
Event Description

Medtronic received report that a patient required an emergent hospitalization for an intraparenchymal hemorrhage (iph) two weeks post pipeline procedure. The patient was treated for an aneurysm located in the ophthalmic segment of the left internal carotid artery. Two pipeline flex devices were implanted successfully with slow stagnation within the aneurysm, as expected. Two weeks post procedure; the patient developed iph with right hemiplegia and partial aphasia and was admitted to the hospital. The imaging studies showed that the iph occurred in the parent vascular territory of the target aneurysm and it was centered in the large parietal lobe with minimal surrounding hypodensity extending to the left lateral ventricle and left central sulcus. It was further reported that the iph was related to the dual antiplatelet treatment; the pru level was reported to be 54 at the time of the hospital admission. The clopidogrel was initially stopped, and was resumed five days later at half dose.

 
Event Description

Medtronic received information that patient was discharged to rehabilitation in stable condition. Additionally, the clopidogrel treatment dose was reduced to 25 mg every four days.

 
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Brand NamePIPELINE FLEX EMBOLIZATION DEVICE
Type of DeviceINTRACRANIAL ANEURYSM FLOW DIVERTER
Manufacturer (Section D)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MEDTRONIC COVIDIEN
9775 toledo way
irvine CA 92618
Manufacturer Contact
tricha miles
9775 toledo way
irvine, CA 92618
9498373700
MDR Report Key5255858
MDR Text Key32354077
Report Number2029214-2015-05174
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP100018.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 11/04/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date04/15/2018
Device MODEL NumberPED-450-14
Device LOT NumberA091101
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 Received11/04/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/16/2015
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: 11/30/2015 Patient Sequence Number: 1
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