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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-400-16
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage, Cerebral (1889)
Event Date 02/03/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4) the pipeline flex will not be returned as it was implanted in the patient. Based on the reported information, there did not appear to have been any device issue during use. The reported ipsilateral hemorrhage is located distal to the pipeline implants. Intracerebral bleeding is a known inherent risk of pipeline procedure and is documented in the pipeline flex instruction for use. The event occurred in the patient post-procedure and its cause cannot be determined from the reported information. It should be noted that the physician used the pipeline flex to treat a blister aneurysm. Per the pipeline flex instructions for use (ifu): ¿the pipeline flex embolization device is indicated for the endovascular treatment of adults (22 years of age or older) with large or giant wide-necked intracranial aneurysms (ias) in the internal carotid artery from the petrous to the superior hypophyseal segments. ¿ mdrs related to this event: 2029214-2016-00123 2029214-2016-00124.
 
Event Description
Medtronic received report that a patient experienced remote ipsilateral hemorrhage two days after pipeline flex implantation. The patient received two pipeline flex implants to treat a blister aneurysm (diameter ~2mm) in the distal right internal carotid artery (ica) immediately proximal to aca. The aneurysm had previously ruptured three months before and was not treated at that time. The physician chose to implant two pipeline flex devices for improved proximal coverage; the physician felt that the previously ruptured aneurysm could benefit from two devices. There was reportedly no difficulties during the implantation procedure. Two days post-procedure, the patient experienced an ipsilateral intraparenchymal hemorrhage (iph) in the posterior superior area of the right hemisphere. The patient presented in the er and was given platelets. The patient had an nihss of 16. The patient is reported to be doing slightly better since the iph.
 
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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 Key5467799
MDR Text Key39277627
Report Number2029214-2016-00123
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
Report Date 02/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/09/2018
Device Model NumberPED-400-16
Device Lot NumberA087466
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 Received02/04/2016
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/10/2015
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: 02/29/2016 Patient Sequence Number: 1
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