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U.S. Department of Health and Human Services

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

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COVIDIEN (IRVINE) PIPELINE EMBOLIZATION DEVICE INTRACRANIAL ANEURYSM FLOW DIVERTER Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage, Cerebral (1889); Paresis (1998)
Event Date 04/18/2017
Event Type  Injury  
Manufacturer Narrative
Brunozzi, d. , shakur, s. F. , hussein, a. E. , charbel, f. T. , <(>&<)> alaraj, a. (2017). Middle cerebral artery flow velocity increases more in patients with delayed intraparenchymal hemorrhage after pipeline. Journal of neurointerventional surgery, 10(3), 249-251. Doi:10. 1136/neurintsurg-2017-013042 the pipeline devices will not be returned for evaluation as they remain implanted in the patients. Based on the provided information, there does not appear to have been any defect of the devices during use. The events occurred in the patients post-procedure and the causes could not be conclusively determined from the provided information. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Medtronic literature review found reports of delayed ipsilateral intraparenchymal hemorrhage (diph) after pipeline placement. The purpose of this article was to assess middle cerebral artery (mca) flow velocity changes after pipeline embolization device (ped) deployment in order to better understand the pathophysiology of diph. The authors retrospectively reviewed 10 patients who underwent ped placement of aneurysms proximal to the internal carotid artery (ica) terminus. All 10 patients were female; the mean age was 52 years. The article states that two patients experienced diph after pipeline placement, both within 48 hours of the procedure: - one patient developed diph on post-procedure day 1; the hemorrhage was located in the parietal-occipital lobe, causing permanent left hemiplegia. - the second patient presented with diph on post-procedure day 2 and the hemorrhage involved the parietal lobe, resulting in permanent left side sensory loss.
 
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Brand NamePIPELINE 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 Key7448871
MDR Text Key106137587
Report Number2029214-2018-00312
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P100018.S004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received03/26/2018
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: 04/20/2018 Patient Sequence Number: 1
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